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PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.

NCT01297088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-01-21

No results posted yet for this study

Summary

The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.

Conditions

  • Diagnostic Imaging

Interventions

DRUG

BAY86-9596

One single dose administration of a diagnostic agent

Sponsors & Collaborators

  • Life Molecular Imaging SA

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Singapore

Study Locations

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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 NCT01297088 on ClinicalTrials.gov