ID

39081

Description

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations; ODM derived from: https://clinicaltrials.gov/show/NCT01089998

Link

https://clinicaltrials.gov/show/NCT01089998

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 NCT01089998

English

Eligibility Diagnostic Imaging NCT01089998

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy volunteers only
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
males/females ≥ 50 years and ≤ 65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
Description

Malignant Neoplasms | Inflammation

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0021368
males/females ≥ 30 and ≤ 80 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients had an fdg pet/ct for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
Description

Tumor Mass FDG PET-CT Scan | Tumor Mass TNM clinical staging | Restaging | Disease Response Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C4521453
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C4331246
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C1516048
1. nsclc (non small cell lung cancer), or
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. adenocarcinoma of the breast (female patients) or
Description

Breast adenocarcinoma | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0079399
3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
Description

Squamous cell carcinoma of the head and neck

Data type

boolean

Alias
UMLS CUI [1]
C1168401
4. patients with confirmed/known inflammatory focus/foci after fdg-pet/ct imaging
Description

Foci inflammatory | Status post FDG PET-CT Scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0205234
UMLS CUI [1,2]
C0333348
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C4521453
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria for all healthy volunteers and patients:
Description

Healthy Volunteers | Patients

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0030705
any concomitant disease (for healthy volunteers) and for patients any concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
Description

Comorbidity compromises Study Subject Participation Status | Comorbidity Severe | Comorbidity Uncontrolled | Disease Unstable | Poorly controlled diabetes mellitus | Congestive heart failure | Myocardial Infarction | Other Coding | Hypertensive disease Unstable | Uncontrolled hypertension | Chronic Kidney Diseases | Chronic liver disease | Lung disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0443343
UMLS CUI [5]
C0554876
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0027051
UMLS CUI [8]
C3846158
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
for healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Component Preparation

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013227
tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
Description

Tumor Patients | Inflammatory disorder | Image Overlapping | Inflammatory lesion | Tumor Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0030705
UMLS CUI [2]
C1290884
UMLS CUI [3,1]
C1704922
UMLS CUI [3,2]
C1948020
UMLS CUI [4]
C3872830
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0221198
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Similar models

Eligibility Diagnostic Imaging NCT01089998

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
healthy volunteers only
boolean
C1708335 (UMLS CUI [1])
Age
Item
males/females ≥ 50 years and ≤ 65 years of age
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasms | Inflammation
Item
cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
boolean
C0006826 (UMLS CUI [1])
C0021368 (UMLS CUI [2])
Age
Item
males/females ≥ 30 and ≤ 80 years of age
boolean
C0001779 (UMLS CUI [1])
Tumor Mass FDG PET-CT Scan | Tumor Mass TNM clinical staging | Restaging | Disease Response Assessment
Item
patients had an fdg pet/ct for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
boolean
C3273930 (UMLS CUI [1,1])
C4521453 (UMLS CUI [1,2])
C3273930 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C4331246 (UMLS CUI [3])
C1704632 (UMLS CUI [4,1])
C1516048 (UMLS CUI [4,2])
Non-Small Cell Lung Carcinoma
Item
1. nsclc (non small cell lung cancer), or
boolean
C0007131 (UMLS CUI [1])
Breast adenocarcinoma | Gender
Item
2. adenocarcinoma of the breast (female patients) or
boolean
C0858252 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Squamous cell carcinoma of the head and neck
Item
3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
boolean
C1168401 (UMLS CUI [1])
Foci inflammatory | Status post FDG PET-CT Scan
Item
4. patients with confirmed/known inflammatory focus/foci after fdg-pet/ct imaging
boolean
C0205234 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C4521453 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Healthy Volunteers | Patients
Item
exclusion criteria for all healthy volunteers and patients:
boolean
C1708335 (UMLS CUI [1])
C0030705 (UMLS CUI [2])
Comorbidity compromises Study Subject Participation Status | Comorbidity Severe | Comorbidity Uncontrolled | Disease Unstable | Poorly controlled diabetes mellitus | Congestive heart failure | Myocardial Infarction | Other Coding | Hypertensive disease Unstable | Uncontrolled hypertension | Chronic Kidney Diseases | Chronic liver disease | Lung disease Severe
Item
any concomitant disease (for healthy volunteers) and for patients any concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay86-9596, 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])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0554876 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C3846158 (UMLS CUI [8])
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])
Hypersensitivity Investigational New Drugs | Hypersensitivity Component Preparation
Item
for healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Tumor Patients | Inflammatory disorder | Image Overlapping | Inflammatory lesion | Tumor Lesion
Item
tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
boolean
C0027651 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
C1704922 (UMLS CUI [3,1])
C1948020 (UMLS CUI [3,2])
C3872830 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
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