check_circleStudy Completed

Diagnostic Imaging

PET/CT (positron emission tomography/computed tomography) imaging for safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and healthy volunteers

Trial purpose

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal
14
Trial Dates
February 2011 - November 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
[18F]PMPA (BAY1075553)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
University of Michigan Health SystemAnn Arbor, 48109-0028, United States
Completed
Krankenhaus der Barmherzigen Schwestern LinzLinz, 4010, Austria

Primary Outcome

  • Safety parameters, for example laboratory and electrocardiogram abnormalities
    date_rangeTime Frame:
    Day 2
    enhanced_encryption
    Safety Issue:
    Yes
  • Effective radiation dose given in mSv (milliSievert) in healthy volunteers
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall lesion detection rate
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Accumulation score in all lesions identified with BAY1075553
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, multi center PET/CT study for investigation of safety, tolerability, biodistribution and diagnostic performance of the 18F labeled PET tracer BAY1075553 following a single intravenous administration of 300 MBq 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
2