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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

NCT00975299 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-06-26

No results posted yet for this study

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

Conditions

  • Diagnostic Imaging

Interventions

DRUG

BAY86-4367

Cancer patients, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, PET/CT

DRUG

BAY86-4367

Healthy volunteers, single intravenous bolus injection of 300 MBq BAY86-4367 on day one of the treatment period, whole body PET/CT for determination of effective dose., kinetics of BAY86-4367 in blood

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Germany
  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975299 on ClinicalTrials.gov