Pilot Study of 18F-FLT PET

February 22, 2012 updated by: University of Wisconsin, Madison

Pilot Study of 18F-FLT Pet Imaging in Cancer Patients

Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and clinis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Able to tolerate a PET/CT scan
  • Age of 18 or older
  • signed informed consent
  • being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer

Exclusion Criteria:

  • Prior XRT to site being studied
  • severe claustrophobia or inability to tolerate PET/CT
  • unable to provide written consent
  • pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2. Head and neck
Imaging with 18F-FLT PET
Procedure: Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
Experimental: 3. Lung
Imaging with 18F-FLT PET
Procedure: Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
Experimental: 4. prostate
Imaging with 18F-FLT PET
Procedure: Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
Experimental: 5. esophagus
Imaging with 18F-FLT PET
Procedure: Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
Experimental: 1.CNS
Imaging with 18F-FLT PET
Procedure: Imaging with 18F-FLT PET
Imaging with 18F-FLT PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging
Time Frame: end of study
end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Robert Jeraj, Ph.D., University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 3, 2008

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-2006-0280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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