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Pilot Study of 18F-FLT PET

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585741
First received: December 21, 2007
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of 18F-FLT Pet Imaging in Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585741     History of Changes
Other Study ID Numbers: HSC-2006-0280
Study First Received: December 21, 2007
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Brain Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Alovudine
Antiviral Agents

ClinicalTrials.gov processed this record on May 22, 2013