Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Open-label, Multicenter PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY86-4367 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 40 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

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975299

Enrollment

Registered

2009-09-11

Start date

2009-09-30

Completion date

2010-10-31

Last updated

2014-06-26

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 BAY86-4367 in patients with cancer

Interventions

DRUGBAY86-4367

Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT

Study design

Allocation

NON_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 with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).

Exclusion criteria

Design outcomes

Primary

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

Secondary

Measure	Time frame
Electrocardiogram (ECG)	At least 3 times within 8 days after treatment
Blood pressure	At least 3 times within 8 days after treatment
Serum protein	At least 3 times within 8 days after treatment
Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)	Day of study drug administration
Serum GOT (Glutamat-Oxalacetat-Transaminase)	At least 3 times within 8 days after treatment
Adverse events collection	At least 3 times within 8 days after treatment
Serum creatinine	At least 3 times within 8 days after treatment

Countries

Germany, Switzerland

Outcome results

None listed

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