ID

39078

Description

PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01287845

Link

https://clinicaltrials.gov/show/NCT01287845

Keywords

Versions (1)
  1. 11/28/19 11/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diagnostic Imaging NCT01287845

English

Eligibility Diagnostic Imaging NCT01287845

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1: healthy volunteers only
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
- males ≥ 40 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
part 2: prostate cancer patients
Description

Patients Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
males ≥ 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
serum psa (prostate-specific antigen) value above normal.
Description

Serum Prostate Specific Antigen Increased

Data type

boolean

Alias
UMLS CUI [1]
C1883014
patients had an mri and/or a positive [11c] - or [18f] -choline pet/ct for primary diagnosis (note: mri and [11c]-or [18f]-choline pet/ct are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
Description

Principal diagnosis MRI | Principal diagnosis Carbon-11 Choline PET-CT Scan Positive | Principal diagnosis Fluciclovine F-18 PET/CT scan Positive | Prostate cancer recurrent | Primary malignant neoplasm Histology | Adenocarcinoma Histology

Data type

boolean

Alias
UMLS CUI [1,1]
C0332137
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0332137
UMLS CUI [2,2]
C2985492
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0332137
UMLS CUI [3,2]
C1311253
UMLS CUI [3,3]
C1699633
UMLS CUI [3,4]
C1514241
UMLS CUI [4]
C0278838
UMLS CUI [5,1]
C1306459
UMLS CUI [5,2]
C0344441
UMLS CUI [6,1]
C0001418
UMLS CUI [6,2]
C0344441
patients with primary prostate cancer have to be scheduled for prostatectomy
Description

Patients Prostate carcinoma Primary | Prostatectomy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0033573
UMLS CUI [2,2]
C0205539
in patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
Description

Patients Prostate carcinoma Primary | Adenocarcinoma Gleason score | Biopsy Quantity Prostate Location

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C3203027
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0033572
UMLS CUI [3,4]
C1515974
patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
Description

Patients Prostate carcinoma Advanced Primary | Patients Prostate cancer recurrent | Probability High Secondary malignant neoplasm of lymph node | Patients Scheduled Pelvic lymphadenectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C0205225
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0278838
UMLS CUI [3,1]
C0033204
UMLS CUI [3,2]
C0205250
UMLS CUI [3,3]
C0686619
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0205539
UMLS CUI [4,3]
C0193883
part 3: prostate cancer patients -- the criteria for eligibility of part 3 are identical to the ones of part 2. except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.
Description

Patients Prostate carcinoma | Probability High Neoplasm Metastasis | Probability High Secondary malignant neoplasm of lymph node

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0033204
UMLS CUI [2,2]
C0205250
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C0033204
UMLS CUI [3,2]
C0205250
UMLS CUI [3,3]
C0686619
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
Description

Comorbidity Severe | Comorbidity Uncontrolled | Comorbidity Unstable | Exception Prostate carcinoma | Poorly controlled diabetes mellitus | Congestive heart failure | Myocardial Infarction | BAY 1075553 Injection Planned | Hypertensive disease Unstable | Uncontrolled hypertension | Chronic Kidney Disease | Chronic liver disease | Lung disease Severe | Comorbidity compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [5]
C0554876
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0027051
UMLS CUI [8,1]
C3852872
UMLS CUI [8,2]
C1533685
UMLS CUI [8,3]
C1301732
UMLS CUI [9,1]
C0020538
UMLS CUI [9,2]
C0443343
UMLS CUI [10]
C1868885
UMLS CUI [11]
C1561643
UMLS CUI [12]
C0341439
UMLS CUI [13,1]
C0024115
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C0009488
UMLS CUI [14,2]
C2945640
UMLS CUI [14,3]
C2348568
acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
Description

Renal Insufficiency | Etiology Hepatorenal Syndrome | Perioperative Period Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0019212
UMLS CUI [3,1]
C2712230
UMLS CUI [3,2]
C0023911
active inflammatory bowel disease within the last 6 months
Description

Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
acute prostatitis requiring medical treatment within the last 6 months
Description

Prostatitis Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0033581
UMLS CUI [1,2]
C0332121
a non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
Description

Bacterial Infection | Exception Urological system | Requirement Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699869
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0338237
active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
Description

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
Description

Patients Prostate carcinoma Primary | Androgen suppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C1515985
subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Description

Criteria Study Subject Participation Status Excluded | Etiology Scientific | Etiology Compliance behavior | Etiology Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0036397
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1321605
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1113679
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Similar models

Eligibility Diagnostic Imaging NCT01287845

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
part 1: healthy volunteers only
boolean
C1708335 (UMLS CUI [1])
Gender | Age
Item
- males ≥ 40 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Patients Prostate carcinoma
Item
part 2: prostate cancer patients
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Gender | Age
Item
males ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Serum Prostate Specific Antigen Increased
Item
serum psa (prostate-specific antigen) value above normal.
boolean
C1883014 (UMLS CUI [1])
Principal diagnosis MRI | Principal diagnosis Carbon-11 Choline PET-CT Scan Positive | Principal diagnosis Fluciclovine F-18 PET/CT scan Positive | Prostate cancer recurrent | Primary malignant neoplasm Histology | Adenocarcinoma Histology
Item
patients had an mri and/or a positive [11c] - or [18f] -choline pet/ct for primary diagnosis (note: mri and [11c]-or [18f]-choline pet/ct are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
boolean
C0332137 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0332137 (UMLS CUI [2,1])
C2985492 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0332137 (UMLS CUI [3,1])
C1311253 (UMLS CUI [3,2])
C1699633 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
C0278838 (UMLS CUI [4])
C1306459 (UMLS CUI [5,1])
C0344441 (UMLS CUI [5,2])
C0001418 (UMLS CUI [6,1])
C0344441 (UMLS CUI [6,2])
Patients Prostate carcinoma Primary | Prostatectomy Scheduled
Item
patients with primary prostate cancer have to be scheduled for prostatectomy
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0033573 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Patients Prostate carcinoma Primary | Adenocarcinoma Gleason score | Biopsy Quantity Prostate Location
Item
in patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0001418 (UMLS CUI [2,1])
C3203027 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0033572 (UMLS CUI [3,3])
C1515974 (UMLS CUI [3,4])
Patients Prostate carcinoma Advanced Primary | Patients Prostate cancer recurrent | Probability High Secondary malignant neoplasm of lymph node | Patients Scheduled Pelvic lymphadenectomy
Item
patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0278838 (UMLS CUI [2,2])
C0033204 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C0686619 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
C0193883 (UMLS CUI [4,3])
Patients Prostate carcinoma | Probability High Neoplasm Metastasis | Probability High Secondary malignant neoplasm of lymph node
Item
part 3: prostate cancer patients -- the criteria for eligibility of part 3 are identical to the ones of part 2. except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0033204 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0033204 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C0686619 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Severe | Comorbidity Uncontrolled | Comorbidity Unstable | Exception Prostate carcinoma | Poorly controlled diabetes mellitus | Congestive heart failure | Myocardial Infarction | BAY 1075553 Injection Planned | Hypertensive disease Unstable | Uncontrolled hypertension | Chronic Kidney Disease | Chronic liver disease | Lung disease Severe | Comorbidity compromises Study Subject Participation Status
Item
concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0554876 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C3852872 (UMLS CUI [8,1])
C1533685 (UMLS CUI [8,2])
C1301732 (UMLS CUI [8,3])
C0020538 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C1868885 (UMLS CUI [10])
C1561643 (UMLS CUI [11])
C0341439 (UMLS CUI [12])
C0024115 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0009488 (UMLS CUI [14,1])
C2945640 (UMLS CUI [14,2])
C2348568 (UMLS CUI [14,3])
Renal Insufficiency | Etiology Hepatorenal Syndrome | Perioperative Period Transplantation of liver
Item
acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
boolean
C1565489 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0019212 (UMLS CUI [2,2])
C2712230 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
Inflammatory Bowel Disease
Item
active inflammatory bowel disease within the last 6 months
boolean
C0021390 (UMLS CUI [1])
Prostatitis Treatment required for
Item
acute prostatitis requiring medical treatment within the last 6 months
boolean
C0033581 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Bacterial Infection | Exception Urological system | Requirement Antibiotic therapy
Item
a non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699869 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0338237 (UMLS CUI [3,2])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Patients Prostate carcinoma Primary | Androgen suppression
Item
patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1515985 (UMLS CUI [2])
Criteria Study Subject Participation Status Excluded | Etiology Scientific | Etiology Compliance behavior | Etiology Patient safety
Item
subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
boolean
C0243161 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0036397 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C1113679 (UMLS CUI [4,2])
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