Neoplasms
Conditions
Keywords
Prostatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Melanoma, Neoplasm Metastasis
Brief summary
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations. The investigational drug will be given as a single administration in a dose of \</= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
Interventions
DRUGPET tracer (BAY94-9392)
A radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
Sponsors
Life Molecular Imaging SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Males/females \>/= 18 years * Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.) * ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392 * Patient had an \[18F\]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient * No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
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 BAY94-9392, 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 * Previous treatment with BAY94-9392 in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology. | Day 1 |
| Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis. | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Vital Signs | Day 1 and Day 2 |
| Laboratory Findings | Day 1 and Day 2 |
| Standardized uptake value (SUV) | Day 1 |
| Adverse Event Collection | Day 1 and Day 2 |
| Electrocardiograms (ECGs) | Day 1 and Day 2 |
| Standardized uptake value ratio (SUVR) | Day 1 |
Countries
United States
Outcome results
None listed