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])
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])