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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


Phase 1
45 Years
N/A
Not Enrolling
Male
Diagnostic Imaging

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visual assessment of lesions

Outcome Time Frame:

Day of study drug administration

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

13991

NCT ID:

NCT00975299

Start Date:

September 2009

Completion Date:

October 2010

Related Keywords:

  • Diagnostic Imaging
  • Neoplasm
  • PET/CT diagnosis
  • PET tracer
  • Prostatic Neoplasms

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