ID

40816

Beschreibung

HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025; ODM derived from: https://clinicaltrials.gov/show/NCT02095210

Link

https://clinicaltrials.gov/show/NCT02095210

Stichworte

Versionen (1)
  1. 18.05.20 18.05.20 -
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See clinicaltrials.gov

Hochgeladen am

18. Mai 2020

DOI

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Eligibility HER2-positive Breast Cancer NCT02095210

Englisch

Eligibility HER2-positive Breast Cancer NCT02095210

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is > 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (labc: t3-4nxmx or txn2-3mx)
Beschreibung

Breast adenocarcinoma Size Ultrasonography | Breast Carcinoma Advanced Locally TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0041618
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C0474926
3. her2-positiv breast cancer first recurrence
Beschreibung

HER2-positive carcinoma of breast First Relapse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C4054953
4. her2-positiv breast cancer primary metastatic
Beschreibung

HER2-positive carcinoma of breast primary metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1522484
5. her2 status has been determined on biopsy material from the primary tumour and found to be her2-positive, defined as a dako herceptest™ score of 3+ or else 2+ and fish positive
Beschreibung

Primary tumor HER2 Positive HercepTest | Primary tumor HER2 Positive FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C1512416
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C0162789
6. [18f]fdg pet/cect performed within 7 days before administration of imp
Beschreibung

FDG-Positron Emission Tomography and Computed Tomography Scan

Datentyp

boolean

Alias
UMLS CUI [1]
C4521453
7. ecog performance status of =< 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. hematological, liver and renal function test results within the following limits:
Beschreibung

Hematologic function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
white blood cell count: > 2.0 x 10^9/l
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
haemoglobin: > 5.0 mmol/l
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
platelets: > 50.0 x 10^9/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
alt, alp: =< 3 times upper limit of normal
Beschreibung

Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201850
bilirubin =< 2.0 times upper limit of normal
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine: within normal limits
Beschreibung

Serum creatinine normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438244
9. a negative pregnancy test (serum beta-hcg) at screening for all subjects of childbearing potential
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
10. subject is capable to undergo the diagnostic investigations to be performed in the study
Beschreibung

Capability Receive Diagnostic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0430022
11. informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known hypersensitivity to dotarem® 2. active known autoimmune disease or history of autoimmune disease 3. active serious infection according to investigator evaluation 4. known hiv positive or chronically active hepatitis b or c 5. administration of other investigational medicinal product within 30 days of screening
Beschreibung

Hypersensitivity Dotarem | Autoimmune Disease | Communicable Disease Serious | HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0114857
UMLS CUI [2]
C0004364
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0019699
UMLS CUI [5]
C0524909
UMLS CUI [6]
C0524910
UMLS CUI [7]
C0013230
6. pregnant or breast-feeding 7. women capable of childbearing not using a sufficient non-hormonal method of birth control 8. other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the imp, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Contraceptive methods Except Hormonal contraception | Cancer Other Primary | Brain Tumor, Primary | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Limited Controlled | Signs Disease Other | Signs Metabolic Diseases | Signs Mental disorders | Disease Investigational New Drugs Contraindicated | Condition Investigational New Drugs Contraindicated | Disease Influence Protocol Compliance | Condition Influence Protocol Compliance | Disease At risk Complications | Condition At risk Complications

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C2985296
UMLS CUI [5,1]
C1707251
UMLS CUI [5,2]
C0205225
UMLS CUI [6]
C0750974
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0851140
UMLS CUI [7,3]
C1522326
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0553723
UMLS CUI [8,3]
C1522326
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0007117
UMLS CUI [9,3]
C0439801
UMLS CUI [9,4]
C2911690
UMLS CUI [10,1]
C0311392
UMLS CUI [10,2]
C0012634
UMLS CUI [10,3]
C0205394
UMLS CUI [11,1]
C0311392
UMLS CUI [11,2]
C0025517
UMLS CUI [12,1]
C0311392
UMLS CUI [12,2]
C0004936
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0013230
UMLS CUI [13,3]
C1444657
UMLS CUI [14,1]
C0348080
UMLS CUI [14,2]
C0013230
UMLS CUI [14,3]
C1444657
UMLS CUI [15,1]
C0012634
UMLS CUI [15,2]
C4054723
UMLS CUI [15,3]
C0525058
UMLS CUI [16,1]
C0348080
UMLS CUI [16,2]
C4054723
UMLS CUI [16,3]
C0525058
UMLS CUI [17,1]
C0012634
UMLS CUI [17,2]
C1444641
UMLS CUI [17,3]
C0009566
UMLS CUI [18,1]
C0348080
UMLS CUI [18,2]
C1444641
UMLS CUI [18,3]
C0009566
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Ähnliche Modelle

Eligibility HER2-positive Breast Cancer NCT02095210

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is > 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Size Ultrasonography | Breast Carcinoma Advanced Locally TNM Breast tumor staging
Item
2. histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (labc: t3-4nxmx or txn2-3mx)
boolean
C0858252 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0474926 (UMLS CUI [2,4])
HER2-positive carcinoma of breast First Relapse
Item
3. her2-positiv breast cancer first recurrence
boolean
C1960398 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
HER2-positive carcinoma of breast primary metastatic
Item
4. her2-positiv breast cancer primary metastatic
boolean
C1960398 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
Primary tumor HER2 Positive HercepTest | Primary tumor HER2 Positive FISH
Item
5. her2 status has been determined on biopsy material from the primary tumour and found to be her2-positive, defined as a dako herceptest™ score of 3+ or else 2+ and fish positive
boolean
C0677930 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1512416 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
FDG-Positron Emission Tomography and Computed Tomography Scan
Item
6. [18f]fdg pet/cect performed within 7 days before administration of imp
boolean
C4521453 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status of =< 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
8. hematological, liver and renal function test results within the following limits:
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
White Blood Cell Count procedure
Item
white blood cell count: > 2.0 x 10^9/l
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin: > 5.0 mmol/l
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelets: > 50.0 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
alt, alp: =< 3 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin =< 2.0 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Serum creatinine normal
Item
serum creatinine: within normal limits
boolean
C0438244 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
9. a negative pregnancy test (serum beta-hcg) at screening for all subjects of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Capability Receive Diagnostic procedure
Item
10. subject is capable to undergo the diagnostic investigations to be performed in the study
boolean
C2698977 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Informed Consent
Item
11. informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Dotarem | Autoimmune Disease | Communicable Disease Serious | HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic | Investigational New Drugs
Item
1. known hypersensitivity to dotarem® 2. active known autoimmune disease or history of autoimmune disease 3. active serious infection according to investigator evaluation 4. known hiv positive or chronically active hepatitis b or c 5. administration of other investigational medicinal product within 30 days of screening
boolean
C0020517 (UMLS CUI [1,1])
C0114857 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0019699 (UMLS CUI [4])
C0524909 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
C0013230 (UMLS CUI [7])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Contraceptive methods Except Hormonal contraception | Cancer Other Primary | Brain Tumor, Primary | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Limited Controlled | Signs Disease Other | Signs Metabolic Diseases | Signs Mental disorders | Disease Investigational New Drugs Contraindicated | Condition Investigational New Drugs Contraindicated | Disease Influence Protocol Compliance | Condition Influence Protocol Compliance | Disease At risk Complications | Condition At risk Complications
Item
6. pregnant or breast-feeding 7. women capable of childbearing not using a sufficient non-hormonal method of birth control 8. other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the imp, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C2985296 (UMLS CUI [4,3])
C1707251 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0750974 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0851140 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0553723 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0007117 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
C2911690 (UMLS CUI [9,4])
C0311392 (UMLS CUI [10,1])
C0012634 (UMLS CUI [10,2])
C0205394 (UMLS CUI [10,3])
C0311392 (UMLS CUI [11,1])
C0025517 (UMLS CUI [11,2])
C0311392 (UMLS CUI [12,1])
C0004936 (UMLS CUI [12,2])
C0012634 (UMLS CUI [13,1])
C0013230 (UMLS CUI [13,2])
C1444657 (UMLS CUI [13,3])
C0348080 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444657 (UMLS CUI [14,3])
C0012634 (UMLS CUI [15,1])
C4054723 (UMLS CUI [15,2])
C0525058 (UMLS CUI [15,3])
C0348080 (UMLS CUI [16,1])
C4054723 (UMLS CUI [16,2])
C0525058 (UMLS CUI [16,3])
C0012634 (UMLS CUI [17,1])
C1444641 (UMLS CUI [17,2])
C0009566 (UMLS CUI [17,3])
C0348080 (UMLS CUI [18,1])
C1444641 (UMLS CUI [18,2])
C0009566 (UMLS CUI [18,3])
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