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

Phase 1

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Bombesin (68Ga) labeled (BAY86-7548)

• Registration Number: NCT01205321
• Lead Sponsor: Life Molecular Imaging SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Bombesin (68Ga) labeled (BAY86-7548)	-
Arm 2	Bombesin (68Ga) labeled (BAY86-7548)	-

Primary Outcome Measures

Name	Time	Method
Visual assessment of lesions	Day of study drug administration

Secondary Outcome Measures

Name	Time	Method
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