Clinical trial · Interventional
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnostic Imaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bombesin (68Ga) labeled (BAY86-7548) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Bombesin (68Ga) labeled (BAY86-7548)
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: Bombesin (68Ga) labeled (BAY86-7548)
Primary outcomes (1)
- measure
- Visual assessment of lesions
- timeFrame
- Day of study drug administration
Secondary outcomes (7)
- measure
- Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy volunteers: * males, \>/=50 and \</= 65 years of age * Cancer patients: * males \>/= 45 years of age * Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed. * The prostate cancer is histologically confirmed and results of histology are available. * Patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation. * Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy. Exclusion Criteria: * 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 BAY86-7548, 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.
References
Publications (0)
Data not yet available