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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01205321

Enrollment

Registered

2010-09-20

Start date

2010-11-30

Completion date

2011-12-31

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Imaging

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 BAY86-7548 in patients with cancer.

Interventions

DRUGBombesin (68Ga) labeled (BAY86-7548)

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Visual assessment of lesions	Day of study drug administration

Secondary

Measure	Time frame
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)	Day of study drug administration
ECG (significant abnormalities)	At least 3 times until one day after treatment
Blood pressure	At least 3 times until one day after treatment
Serum protein	At least 3 times until one day after treatment
Serum creatinine	At least 3 times until one day after treatment
Serum GOT (Glutamat-Oxalacetat-Transaminase)	At least 3 times until one day after treatment
Adverse events collection	Continuously for at least 5 days after treatment

Countries

Finland, Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026