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

Phase 1

Terminated

• Conditions: Diagnostic Imaging
• Interventions: Drug: BAY86-4367

• Registration Number: NCT00975299
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 16

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY86-4367	-
Arm 2	BAY86-4367	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram (ECG)	At least 3 times within 8 days after treatment
Serum creatinine	At least 3 times within 8 days after treatment
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
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