ID

41505

Description

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains information about the PET investigation. The PET investigation form is for patients eligible for the PET sub-study of DELCODE only. Two PET investigations are to be conducted: a baseline investigation once eligible and a follow-up investigation 24 months after the baseline PET.

Link

https://www.dzne.de/en/research/studies/clinical-studies/delcode/

Keywords

Versions (1)
  1. 10/30/20 10/30/20 -
Copyright Holder

DZNE (German Center for Neurodegenerative Diseases)

Uploaded on

October 30, 2020

DOI

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License

Creative Commons BY-NC 4.0
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DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study

German ( localization.languageCode.DE )

PET Investigation

1 forms  
  1. StudyEvent: ODM
    1. PET Investigation
Administrative Daten
Description

Administrative Daten

Alias
UMLS CUI-1
C1320722
Studien ID
Description

Study ID

Data type

text

Alias
UMLS CUI [1]
C2826693
Visitendatum
Description

Tag Monat Jahr

Data type

date

Alias
UMLS CUI [1]
C1320303
PET‐Untersuchungszeitpunkt:
Description

PET-Investigation - Point in time

Data type

integer

Alias
UMLS CUI [1,1]
C0439547
UMLS CUI [1,2]
C0032743
FBB-PET-Untersuchung
Description

FBB-PET-Untersuchung

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C3818757
FBB-PET
Description

FBB-PET

Data type

boolean

Alias
UMLS CUI [1,1]
C3818757
UMLS CUI [1,2]
C0032743
Datum des Untersuchungstags
Description

Date of investigation

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032743
Untersuchungszeitpunkt
Description

Time of investigation

Data type

text

Alias
UMLS CUI [1,1]
C1442880
UMLS CUI [1,2]
C0032743
Wurde die PET-Untersuchung erfolgreich durchgeführt?
Description

PET investigation successfully performed

Data type

boolean

Alias
UMLS CUI [1,1]
C3258067
UMLS CUI [1,2]
C0032743
Proband krank / nicht erschienen
Description

Sick proband / Proband didn't appear

Data type

boolean

Alias
UMLS CUI [1]
C2010702
UMLS CUI [2]
C1548414
Fehlende Einwilligung durch Proband/in
Description

Informed Consent missing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
Scanner oder Tracer nicht verfügbar
Description

Scanner or tracer not available

Data type

boolean

Alias
UMLS CUI [1,1]
C5208732
UMLS CUI [1,2]
C0686905
UMLS CUI [2,1]
C0182349
UMLS CUI [2,2]
C0686905
Scanner-Ausfall nach Injektion
Description

Scanner malfunction after injection

Data type

boolean

Alias
UMLS CUI [1,1]
C0182349
UMLS CUI [1,2]
C1881681
UMLS CUI [1,3]
C1548614
UMLS CUI [1,4]
C1272883
Datenverlust nach Scan
Description

Loss of data after scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1880251
UMLS CUI [1,2]
C1548614
UMLS CUI [1,3]
C0032743
Sonstige
Description

Other reasons for failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C5200924
UMLS CUI [1,3]
C0032743
Bitte Gründe benennen
Description

Name reasons

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C5200924
UMLS CUI [1,3]
C0032743
UMLS CUI [1,4]
C2348235
Wurde das Radiopharmazeutikum injiziert?
Description

Injection of radiopharmaceutical

Data type

boolean

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0182638
Komplett unterschriebene studienspezifische Probandeneinwilligung für PET-Studie vorhanden?
Description

Informed consent signed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
PET-Einwilligung
Description

PET consent

Data type

integer

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0021430
PET-Ausschlusskriterien tagesaktuell geprüft?
Description

PET - exclusion criteria examined daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
PET-Ausschlusskriterien
Description

PET exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032743
MRT-Ausschlusskriterien tagesaktuell geprüft? (nur bei PET-MRT)
Description

MRI exclusion criteria examined (only PET-MRI)

Data type

boolean

Alias
UMLS CUI [1,1]
C3641326
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
MRT-Ausschlusskriterien
Description

MRI exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C3641326
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
Medikamenteneinnahme am Untersuchungstag
Description

Medication intake on investigation day

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C2584899
Arzneimittel
Description

Pharmaceutical preparation

Data type

text

Alias
UMLS CUI [1]
C0013227
Injizierte Dosis (berechnet)
Description

Bitte Werte vor und nach Injektion nicht einfach subtrahieren, sondern mit Dosisrechner den zwischenzeitlichen Verfall bis/seit Injektion korrigieren

Data type

float

Measurement units
  • MBq
Alias
UMLS CUI [1]
C2986768
MBq
Hat die injizierte Aktivität die BfS-genehmigte Maximaldosis für FBB-Scans überschritten?
Description

Falls BfS-pflichtiger Proband

Data type

boolean

Alias
UMLS CUI [1,1]
C2986768
UMLS CUI [1,2]
C4296997
UMLS CUI [1,3]
C0752079
UMLS CUI [1,4]
C0032743
UMLS CUI [1,5]
C3818757
Gesamt Dosis-Längen-Produkt (DLP) (nur bei PET-CT)
Description

<div>

Data type

float

Measurement units
  • mGy*cm
Alias
UMLS CUI [1,1]
C0439810
UMLS CUI [1,2]
C3539930
UMLS CUI [1,3]
C1699633
mGy*cm
Medizinische Auffälligkeiten oder andere besondere Vorkommnisse während oder nach der Untersuchung?
Description

Medical abnormalities or other special incidents during or after the investigation

Data type

boolean

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1707834
UMLS CUI [1,4]
C4321457
UMLS CUI [2,1]
C0205555
UMLS CUI [2,2]
C1551358
UMLS CUI [2,3]
C1707834
UMLS CUI [2,4]
C4321457
Welche?
Description

Medical abnormalities or other special incidents during or after the investigation - specification

Data type

text

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1707834
UMLS CUI [1,4]
C4321457
UMLS CUI [1,5]
C2348235
UMLS CUI [2,1]
C0205555
UMLS CUI [2,2]
C1551358
UMLS CUI [2,3]
C1707834
UMLS CUI [2,4]
C4321457
UMLS CUI [2,5]
C2348235
(Serious) Adverse Events umgehend gemeldet? (Adverse Event Reporting Form des Herstellers) (nur für DELCODE relevant)
Description

Falls zutreffend: Gemäß der Studienspezifischen Vorgaben

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205548
UMLS CUI [1,3]
C4319718
Hinweise auf nicht studienbezogene klinische Auffälligkeiten in Transmission oder Emission?
Description

Z.B. Verletzungen am Schädelknochen, Tumore oder Entzündungen

Data type

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2986746
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C2986834
Welche?
Description

Evidence of not study-related clinical abnormalities in transmission or emission - specification

Data type

text

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2986746
UMLS CUI [1,5]
C2348235
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C2986834
UMLS CUI [2,5]
C2348235
Anmerkungen
Description

Notes

Data type

text

Alias
UMLS CUI [1]
C0947611
FDG-PET
Description

FDG-PET

Alias
UMLS CUI-1
C3641247
FDG-PET
Description

FDG-PET

Data type

boolean

Alias
UMLS CUI [1]
C3641247
Datum des Untersuchungstags
Description

Date of investigation - FDG-PET

Data type

date

Alias
UMLS CUI [1,1]
C3641247
UMLS CUI [1,2]
C0011008
Untersuchungszeitpunkt
Description

Point in time of investigation - FDG-PET

Data type

text

Alias
UMLS CUI [1,1]
C3641247
UMLS CUI [1,2]
C1442880
Wurde die PET-Untersuchung erfolgreich durchgeführt?
Description

FDG-PET investigation successfully performed

Data type

boolean

Alias
UMLS CUI [1,1]
C3258067
UMLS CUI [1,2]
C3641247
Proband krank / nicht erschienen
Description

Sick proband / Proband didn't appear

Data type

boolean

Alias
UMLS CUI [1]
C2010702
UMLS CUI [2]
C1548414
Fehlende Einwilligung durch Proband/in
Description

Informed Consent missing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
Scanner oder Tracer nicht verfügbar
Description

Scanner or Tracer not available

Data type

boolean

Alias
UMLS CUI [1,1]
C5208732
UMLS CUI [1,2]
C1706613
UMLS CUI [2,1]
C3641247
UMLS CUI [2,2]
C1706613
Blutzuckerspiegel über Grenzwert
Description

Hyperglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0020456
Scanner-Ausfall nach Injektion
Description

Scanner malfunction after injection

Data type

text

Alias
UMLS CUI [1,1]
C3641247
UMLS CUI [1,2]
C1881681
UMLS CUI [1,3]
C1548614
UMLS CUI [1,4]
C1272883
Datenverlust nach Scan
Description

Loss of data after scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1880251
UMLS CUI [1,2]
C1548614
UMLS CUI [1,3]
C3641247
Sonstige
Description

Other reasons for failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C5200924
UMLS CUI [1,3]
C3641247
Bitte Gründe benennen
Description

Name reasons

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C5200924
UMLS CUI [1,3]
C0032743
UMLS CUI [1,4]
C2348235
Wurde das Radiopharmazeutikum injiziert?
Description

Injection of radiopharmaceutical

Data type

boolean

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0182638
Komplett unterschriebene studienspezifische Probandeneinwilligung für PET-Studie vorhanden?
Description

Informed consent signed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
PET-Einwilligung
Description

PET consent

Data type

integer

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0021430
PET-Ausschlusskriterien tagesaktuell geprüft?
Description

PET - exclusion criteria examined daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
PET-Ausschlusskriterien
Description

PET exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032743
MRT-Ausschlusskriterien tagesaktuell geprüft? (nur bei PET-MRT)
Description

MRI exclusion criteria examined (only PET-MRI)

Data type

boolean

Alias
UMLS CUI [1,1]
C3641326
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
MRT-Ausschlusskriterien
Description

MRI exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C3641326
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0332128
UMLS CUI [1,4]
C0521116
Medikamenteneinnahme am Untersuchungstag
Description

Medication intake on investigation day

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2584899
Arzneimittel
Description

Pharmaceutical preparation

Data type

text

Alias
UMLS CUI [1]
C0013227
Injizierte Dosis (berechnet)
Description

Bitte Werte vor und nach Injektion nicht einfach subtrahieren, sondern mit Dosisrechner den zwischenzeitlichen Verfall bis/seit Injektion korrigieren

Data type

float

Measurement units
  • MBq
Alias
UMLS CUI [1]
C2986768
MBq
Hat die injizierte Aktivität die BfS-genehmigte Maximaldosis für FBB-Scans überschritten?
Description

Falls BfS-pflichtiger Proband

Data type

boolean

Alias
UMLS CUI [1,1]
C2986768
UMLS CUI [1,2]
C4296997
UMLS CUI [1,3]
C0752079
UMLS CUI [1,4]
C0032743
UMLS CUI [1,5]
C3818757
Gesamt Dosis-Längen-Produkt (DLP) (nur bei PET-CT)
Description

<div>

Data type

float

Measurement units
  • mGy*cm
Alias
UMLS CUI [1,1]
C0439810
UMLS CUI [1,2]
C3539930
UMLS CUI [1,3]
C1699633
mGy*cm
Medizinische Auffälligkeiten oder andere besondere Vorkommnisse während oder nach der Untersuchung?
Description

Medical abnormalities or other special incidents during or after the investigation

Data type

boolean

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1707834
UMLS CUI [1,4]
C4321457
UMLS CUI [2,1]
C0205555
UMLS CUI [2,2]
C1551358
UMLS CUI [2,3]
C1707834
UMLS CUI [2,4]
C4321457
Welche?
Description

Medical abnormalities or other special incidents during or after the investigation - specification

Data type

text

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1707834
UMLS CUI [1,4]
C4321457
UMLS CUI [1,5]
C2348235
UMLS CUI [2,1]
C0205555
UMLS CUI [2,2]
C1551358
UMLS CUI [2,3]
C1707834
UMLS CUI [2,4]
C4321457
UMLS CUI [2,5]
C2348235
Hinweise auf nicht studienbezogene klinische Auffälligkeiten in Transmission oder Emission?
Description

Z.B. Verletzungen am Schädelknochen, Tumore oder Entzündungen

Data type

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2986746
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C2986834
Welche?
Description

Evidence of not study-related clinical abnormalities in transmission or emission - specification

Data type

text

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2986746
UMLS CUI [1,5]
C2348235
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C2986834
UMLS CUI [2,5]
C2348235
Anmerkungen
Description

Notes

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

PET Investigation

1 forms
  1. StudyEvent: ODM
    1. PET Investigation
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Daten
C1320722 (UMLS CUI-1)
Study ID
Item
Studien ID
text
C2826693 (UMLS CUI [1])
Date of visit
Item
Visitendatum
date
C1320303 (UMLS CUI [1])
Item
PET‐Untersuchungszeitpunkt:
integer
C0439547 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
PET-Investigation - Point in time)
Code List
PET‐Untersuchungszeitpunkt:
CL Item
Baseline‐PET (P0) (1)
CL Item
Follow‐Up‐PET nach 24 Monaten (P24) (2)
Item Group
FBB-PET-Untersuchung
C0032743 (UMLS CUI-1)
C3818757 (UMLS CUI-2)
FBB-PET
Item
FBB-PET
boolean
C3818757 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
Date of investigation
Item
Datum des Untersuchungstags
date
C0011008 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
Time of investigation
Item
Untersuchungszeitpunkt
text
C1442880 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
PET investigation successfully performed
Item
Wurde die PET-Untersuchung erfolgreich durchgeführt?
boolean
C3258067 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
Sick proband / Proband didn't appear
Item
Proband krank / nicht erschienen
boolean
C2010702 (UMLS CUI [1])
C1548414 (UMLS CUI [2])
Informed Consent missing
Item
Fehlende Einwilligung durch Proband/in
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Scanner or tracer not available
Item
Scanner oder Tracer nicht verfügbar
boolean
C5208732 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C0182349 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
Scanner malfunction after injection
Item
Scanner-Ausfall nach Injektion
boolean
C0182349 (UMLS CUI [1,1])
C1881681 (UMLS CUI [1,2])
C1548614 (UMLS CUI [1,3])
C1272883 (UMLS CUI [1,4])
Loss of data after scan
Item
Datenverlust nach Scan
boolean
C1880251 (UMLS CUI [1,1])
C1548614 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Other reasons for failure
Item
Sonstige
boolean
C3840932 (UMLS CUI [1,1])
C5200924 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Name reasons
Item
Bitte Gründe benennen
text
C3840932 (UMLS CUI [1,1])
C5200924 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Injection of radiopharmaceutical
Item
Wurde das Radiopharmazeutikum injiziert?
boolean
C1272883 (UMLS CUI [1,1])
C0182638 (UMLS CUI [1,2])
Informed consent signed
Item
Komplett unterschriebene studienspezifische Probandeneinwilligung für PET-Studie vorhanden?
boolean
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
Item
PET-Einwilligung
integer
C0032743 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
PET consent
Code List
PET-Einwilligung
CL Item
Der DZNE-Zuweiser hat die Einwilligungserklärung bereits erhoben, und eine Kopie an die Nuklearmedizin gesandt (1)
CL Item
Die Einwilligungserklärung wurde von Ärzt/innen der Nuklearmedizin eingeholt (2)
PET - exclusion criteria examined daily
Item
PET-Ausschlusskriterien tagesaktuell geprüft?
boolean
C0032743 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
PET-Ausschlusskriterien
integer
C0680251 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
PET exclusion criteria
Code List
PET-Ausschlusskriterien
CL Item
DZNE-PET-Kontraindikationsbogen (Regelfall bei BfS-pflichtigen Probanden) (1)
CL Item
Kliniküblicher Patienteneinwilligungsbogen (Regelfall bei klinisch rechtfertigender Indikation) (2)
MRI exclusion criteria examined (only PET-MRI)
Item
MRT-Ausschlusskriterien tagesaktuell geprüft? (nur bei PET-MRT)
boolean
C3641326 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
MRT-Ausschlusskriterien
integer
C3641326 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
MRI exclusion criteria
Code List
MRT-Ausschlusskriterien
CL Item
DZNE-MRT-Kontraindikationsbogen (1)
CL Item
Kliniküblicher MRT-Patienteneinwilligungsbogen (2)
Item
Medikamenteneinnahme am Untersuchungstag
integer
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,3])
Medication intake on investigation day
Code List
Medikamenteneinnahme am Untersuchungstag
CL Item
Keine (0)
CL Item
Ja (1)
Pharmaceutical preparation
Item
Arzneimittel
text
C0013227 (UMLS CUI [1])
Injected dose
Item
Injizierte Dosis (berechnet)
float
C2986768 (UMLS CUI [1])
Exceeding of permitted maximum dose for FBB scans
Item
Hat die injizierte Aktivität die BfS-genehmigte Maximaldosis für FBB-Scans überschritten?
boolean
C2986768 (UMLS CUI [1,1])
C4296997 (UMLS CUI [1,2])
C0752079 (UMLS CUI [1,3])
C0032743 (UMLS CUI [1,4])
C3818757 (UMLS CUI [1,5])
Total Dose-Length-Product (only PET-CT)
Item
Gesamt Dosis-Längen-Produkt (DLP) (nur bei PET-CT)
float
C0439810 (UMLS CUI [1,1])
C3539930 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
Medical abnormalities or other special incidents during or after the investigation
Item
Medizinische Auffälligkeiten oder andere besondere Vorkommnisse während oder nach der Untersuchung?
boolean
C0205476 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1707834 (UMLS CUI [1,3])
C4321457 (UMLS CUI [1,4])
C0205555 (UMLS CUI [2,1])
C1551358 (UMLS CUI [2,2])
C1707834 (UMLS CUI [2,3])
C4321457 (UMLS CUI [2,4])
Medical abnormalities or other special incidents during or after the investigation - specification
Item
Welche?
text
C0205476 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1707834 (UMLS CUI [1,3])
C4321457 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0205555 (UMLS CUI [2,1])
C1551358 (UMLS CUI [2,2])
C1707834 (UMLS CUI [2,3])
C4321457 (UMLS CUI [2,4])
C2348235 (UMLS CUI [2,5])
Serious Adverse Events immediately reported
Item
(Serious) Adverse Events umgehend gemeldet? (Adverse Event Reporting Form des Herstellers) (nur für DELCODE relevant)
boolean
C1519255 (UMLS CUI [1,1])
C0205548 (UMLS CUI [1,2])
C4319718 (UMLS CUI [1,3])
Evidence of clinical abnormalities in transmission or emission
Item
Hinweise auf nicht studienbezogene klinische Auffälligkeiten in Transmission oder Emission?
boolean
C0332120 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2986746 (UMLS CUI [1,4])
C0332120 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C2986834 (UMLS CUI [2,4])
Evidence of not study-related clinical abnormalities in transmission or emission - specification
Item
Welche?
text
C0332120 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2986746 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0332120 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C2986834 (UMLS CUI [2,4])
C2348235 (UMLS CUI [2,5])
Notes
Item
Anmerkungen
text
C0947611 (UMLS CUI [1])
Item Group
FDG-PET
C3641247 (UMLS CUI-1)
FDG-PET
Item
FDG-PET
boolean
C3641247 (UMLS CUI [1])
Date of investigation - FDG-PET
Item
Datum des Untersuchungstags
date
C3641247 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Point in time of investigation - FDG-PET
Item
Untersuchungszeitpunkt
text
C3641247 (UMLS CUI [1,1])
C1442880 (UMLS CUI [1,2])
FDG-PET investigation successfully performed
Item
Wurde die PET-Untersuchung erfolgreich durchgeführt?
boolean
C3258067 (UMLS CUI [1,1])
C3641247 (UMLS CUI [1,2])
Sick proband / Proband didn't appear
Item
Proband krank / nicht erschienen
boolean
C2010702 (UMLS CUI [1])
C1548414 (UMLS CUI [2])
Informed Consent missing
Item
Fehlende Einwilligung durch Proband/in
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Scanner or Tracer not available
Item
Scanner oder Tracer nicht verfügbar
boolean
C5208732 (UMLS CUI [1,1])
C1706613 (UMLS CUI [1,2])
C3641247 (UMLS CUI [2,1])
C1706613 (UMLS CUI [2,2])
Hyperglycemia
Item
Blutzuckerspiegel über Grenzwert
boolean
C0020456 (UMLS CUI [1])
Scanner malfunction after injection
Item
Scanner-Ausfall nach Injektion
text
C3641247 (UMLS CUI [1,1])
C1881681 (UMLS CUI [1,2])
C1548614 (UMLS CUI [1,3])
C1272883 (UMLS CUI [1,4])
Loss of data after scan
Item
Datenverlust nach Scan
boolean
C1880251 (UMLS CUI [1,1])
C1548614 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
Other reasons for failure
Item
Sonstige
boolean
C3840932 (UMLS CUI [1,1])
C5200924 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
Name reasons
Item
Bitte Gründe benennen
text
C3840932 (UMLS CUI [1,1])
C5200924 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Injection of radiopharmaceutical
Item
Wurde das Radiopharmazeutikum injiziert?
boolean
C1272883 (UMLS CUI [1,1])
C0182638 (UMLS CUI [1,2])
Informed consent signed
Item
Komplett unterschriebene studienspezifische Probandeneinwilligung für PET-Studie vorhanden?
boolean
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
Item
PET-Einwilligung
integer
C0032743 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
PET consent
Code List
PET-Einwilligung
CL Item
Der DZNE-Zuweiser hat die Einwilligungserklärung bereits erhoben, und eine Kopie an die Nuklearmedizin gesandt (1)
CL Item
Die Einwilligungserklärung wurde von Ärzt/innen der Nuklearmedizin eingeholt (2)
PET - exclusion criteria examined daily
Item
PET-Ausschlusskriterien tagesaktuell geprüft?
boolean
C0032743 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
PET-Ausschlusskriterien
integer
C0680251 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
PET exclusion criteria
Code List
PET-Ausschlusskriterien
CL Item
DZNE-PET-Kontraindikationsbogen (Regelfall bei BfS-pflichtigen Probanden) (1)
CL Item
Kliniküblicher Patienteneinwilligungsbogen (Regelfall bei klinisch rechtfertigender Indikation) (2)
MRI exclusion criteria examined (only PET-MRI)
Item
MRT-Ausschlusskriterien tagesaktuell geprüft? (nur bei PET-MRT)
boolean
C3641326 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
MRT-Ausschlusskriterien
integer
C3641326 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0332128 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
MRI exclusion criteria
Code List
MRT-Ausschlusskriterien
CL Item
DZNE-MRT-Kontraindikationsbogen (1)
CL Item
Kliniküblicher MRT-Patienteneinwilligungsbogen (2)
Item
Medikamenteneinnahme am Untersuchungstag
integer
C0013227 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
Medication intake on investigation day
Code List
Medikamenteneinnahme am Untersuchungstag
CL Item
Keine (0)
CL Item
Ja (1)
Pharmaceutical preparation
Item
Arzneimittel
text
C0013227 (UMLS CUI [1])
Injected dose
Item
Injizierte Dosis (berechnet)
float
C2986768 (UMLS CUI [1])
Exceeding of permitted maximum dose for FBB scans
Item
Hat die injizierte Aktivität die BfS-genehmigte Maximaldosis für FBB-Scans überschritten?
boolean
C2986768 (UMLS CUI [1,1])
C4296997 (UMLS CUI [1,2])
C0752079 (UMLS CUI [1,3])
C0032743 (UMLS CUI [1,4])
C3818757 (UMLS CUI [1,5])
Total Dose-Length-Product (only PET-CT)
Item
Gesamt Dosis-Längen-Produkt (DLP) (nur bei PET-CT)
float
C0439810 (UMLS CUI [1,1])
C3539930 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
Medical abnormalities or other special incidents during or after the investigation
Item
Medizinische Auffälligkeiten oder andere besondere Vorkommnisse während oder nach der Untersuchung?
boolean
C0205476 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1707834 (UMLS CUI [1,3])
C4321457 (UMLS CUI [1,4])
C0205555 (UMLS CUI [2,1])
C1551358 (UMLS CUI [2,2])
C1707834 (UMLS CUI [2,3])
C4321457 (UMLS CUI [2,4])
Medical abnormalities or other special incidents during or after the investigation - specification
Item
Welche?
text
C0205476 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1707834 (UMLS CUI [1,3])
C4321457 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0205555 (UMLS CUI [2,1])
C1551358 (UMLS CUI [2,2])
C1707834 (UMLS CUI [2,3])
C4321457 (UMLS CUI [2,4])
C2348235 (UMLS CUI [2,5])
Evidence of clinical abnormalities in transmission or emission
Item
Hinweise auf nicht studienbezogene klinische Auffälligkeiten in Transmission oder Emission?
boolean
C0332120 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2986746 (UMLS CUI [1,4])
C0332120 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C2986834 (UMLS CUI [2,4])
Evidence of not study-related clinical abnormalities in transmission or emission - specification
Item
Welche?
text
C0332120 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2986746 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0332120 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C2986834 (UMLS CUI [2,4])
C2348235 (UMLS CUI [2,5])
Notes
Item
Anmerkungen
text
C0947611 (UMLS CUI [1])
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