Terminated/Withdrawn

Diagnostic imaging

Bayer Identifier:

13991

ClinicalTrials.gov Identifier:

NCT00975299

EudraCT Number:

2008-007460-42

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

45 Years

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
- Exclusion criteria for all healthy volunteers and patients:
-- 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 BAY 86-4367, 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.

Trial summary

Enrollment Goal

Trial Dates

September 2009 - October 2010

Phase

Phase 1

Could I Receive a placebo

Products

Bombesin (18F) labeled (BAY86-4367)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Universitätsspital Zürich	Zürich, 8091, Switzerland
Completed	Klinikum rechts der Isar	München, 81675, Germany

Primary Outcome

Visual assessment of lesions
Time Frame:
Day of study drug administration
Safety Issue:
no

Secondary Outcome

Quantitative analysis of BAY86-4367 uptake into lesions (Standardized Uptake Values = SUVs)
Time Frame:
Day of study drug administration
Safety Issue:
no
Electrocardiogram (ECG)
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes
Blood pressure
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes
Serum protein
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes
Serum creatinine
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes
Adverse events collection
Time Frame:
At least 3 times within 8 days after treatment
Safety Issue:
yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Non-randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.