Diagnostic Imaging, Neoplasms
Conditions
Keywords
Neoplasm, PET/CT diagnosis, PET tracer
Brief summary
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
Interventions
DRUGBAY94-9392
Sponsors
Life Molecular Imaging SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
In Germany Healthy volunteers * Males/females ≥ 50 and ≤ 65 years Patients * Males/females ≥ 35 and ≤ 75 years * histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or * patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or * inflammation with a positive FDG-PET In Korea Patients * Males/females ≥ 35 and ≤ 75 years * histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or * patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or * inflammation (positive FDG-PET mandatory, could be also done as screening examination)
Exclusion criteria
* Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * Known sensitivity to the study drug or components of the preparation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual assessment of lesion | Day of study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram (ECG) | At least twice within 2 days after treatment |
| Blood pressure | At least twice within 2 days after treatment |
| Serum protein | At least twice within 2 days after treatment |
| Serum creatinine | At least twice within 2 days after treatment |
| Serum GOT (Glutamate-Oxalacetate-Transaminase) | At least twice within 2 days after treatment |
| Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) | Day of study drug administration |
| Radiation doses per organ (µGy/MBq) | Day of study drug administration |
| Higher organ dose (HT) | Day of study drug administration |
| Doses per organ (µSv/MBq) | Day of study drug administration |
| Effective dose (µSv/MBq) | Day of study drug administration |
| Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10% | Day of study drug administration |
| Adverse events collection | Continuously for at least 4 days after treatment |
Countries
Germany, South Korea, United States
Outcome results
None listed