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Pilot Study of 18F-FLT PET

Primary Purpose

CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CNS Brain Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Hospital and clinis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

2. Head and neck

3. Lung

4. prostate

5. esophagus

1.CNS

Arm Description

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

Outcomes

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

Secondary Outcome Measures

To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients

Full Information

First Posted
December 21, 2007
Last Updated
February 22, 2012
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00585741
Brief Title
Pilot Study of 18F-FLT PET
Official Title
Pilot Study of 18F-FLT Pet Imaging in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2. Head and neck
Arm Type
Experimental
Arm Description
Imaging with 18F-FLT PET
Arm Title
3. Lung
Arm Type
Experimental
Arm Description
Imaging with 18F-FLT PET
Arm Title
4. prostate
Arm Type
Experimental
Arm Description
Imaging with 18F-FLT PET
Arm Title
5. esophagus
Arm Type
Experimental
Arm Description
Imaging with 18F-FLT PET
Arm Title
1.CNS
Arm Type
Experimental
Arm Description
Imaging with 18F-FLT PET
Intervention Type
Procedure
Intervention Name(s)
Imaging with 18F-FLT PET
Intervention Description
Imaging with 18F-FLT PET
Intervention Type
Procedure
Intervention Name(s)
Imaging with 18F-FLT PET
Intervention Description
Imaging with 18F-FLT PET
Intervention Type
Procedure
Intervention Name(s)
Imaging with 18F-FLT PET
Intervention Description
Imaging with 18F-FLT PET
Intervention Type
Procedure
Intervention Name(s)
Imaging with 18F-FLT PET
Intervention Description
Imaging with 18F-FLT PET
Intervention Type
Procedure
Intervention Name(s)
Imaging with 18F-FLT PET
Intervention Description
Imaging with 18F-FLT PET
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients
Time Frame
end of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jeraj, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and clinis
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Pilot Study of 18F-FLT PET

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