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Pilot Study of 18F-FLT PET

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585741
First Posted: January 3, 2008
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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

Condition Intervention
CNS Brain Metastasis Head and Neck Cancer Lung Cancer Prostate Cancer Esophageal Cancer Procedure: Imaging with 18F-FLT PET

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of 18F-FLT Pet Imaging in Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 15
Study Start Date: December 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585741


Locations
United States, Wisconsin
University of Wisconsin Hospital and clinis
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Robert Jeraj, Ph.D. University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585741     History of Changes
Other Study ID Numbers: HSC-2006-0280
First Submitted: December 21, 2007
First Posted: January 3, 2008
Last Update Posted: February 23, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Esophageal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Alovudine
Antiviral Agents
Anti-Infective Agents