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
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
-
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Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and clinis
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-
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
|
Imaging with 18F-FLT PET
|
|
Experimental: 3. Lung
Imaging with 18F-FLT PET
|
Imaging with 18F-FLT PET
|
|
Experimental: 4. prostate
Imaging with 18F-FLT PET
|
Imaging with 18F-FLT PET
|
|
Experimental: 5. esophagus
Imaging with 18F-FLT PET
|
Imaging with 18F-FLT PET
|
|
Experimental: 1.CNS
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
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.