MedTrace Logo

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

NCT01205321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-01-21

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 BAY86-7548 in patients with cancer.

Conditions

  • Diagnostic Imaging

Interventions

DRUG

Bombesin (68Ga) labeled (BAY86-7548)

Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

DRUG

Bombesin (68Ga) labeled (BAY86-7548)

Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood

Sponsors & Collaborators

  • Life Molecular Imaging SA

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Finland
  • Germany
  • Switzerland

Study Locations

More Related Trials

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 NCT01205321 on ClinicalTrials.gov