Pilot Study of 18F-FLT PET
Pilot Study of 18F-FLT Pet Imaging in Cancer Patients
1 other identifier
interventional
15
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 23, 2012
February 1, 2012
5 years
December 21, 2007
February 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
end of study
Secondary Outcomes (1)
To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
end of study
Study Arms (5)
2. Head and neck
EXPERIMENTALImaging with 18F-FLT PET
3. Lung
EXPERIMENTALImaging with 18F-FLT PET
4. prostate
EXPERIMENTALImaging with 18F-FLT PET
5. esophagus
EXPERIMENTALImaging with 18F-FLT PET
1.CNS
EXPERIMENTALImaging with 18F-FLT PET
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior XRT to site being studied
- severe claustrophobia or inability to tolerate PET/CT
- unable to provide written consent
- pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital and clinis
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Jeraj, Ph.D.
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 3, 2008
Study Start
December 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 23, 2012
Record last verified: 2012-02