Pilot Study of 18F-FLT PET

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585741
• Other study ID #: HSC-2006-0280
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: February 22, 2012
• Start date: December 2006
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CNS Brain Metastasis
• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Prostate Cancer

Intervention

Procedure:
• Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
• Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
• Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
• Imaging with 18F-FLT PET
Imaging with 18F-FLT PET
• Imaging with 18F-FLT PET
Imaging with 18F-FLT PET

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and clinis	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients		end of study	No