3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT00935090
Collaborator
National Cancer Institute (NCI) (NIH)
80
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171
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Study Details

Study Description

Brief Summary

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging to measure tumor proliferation and the DNA synthetic pathway (thymidine kinase levels) in patients with cancer.

Secondary

  • Determine the efficacy of FLT PET imaging in detecting lesions and estimating response to treatment.

OUTLINE: Patients undergo up to four 3'-deoxy-3'-[18F] fluorothymidine positron emission tomography imaging procedures.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
PET scans will be performed to show the distribution throughout the body of substances containing a small amount of radioactive material.PET scans will be performed to show the distribution throughout the body of substances containing a small amount of radioactive material.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Study Start Date :
Sep 1, 2009
Anticipated Primary Completion Date :
Feb 9, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3'-deoxy-3'-[18F]fluorothymidine

The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body.

Device: 3'-deoxy-3'-[18F]fluorothymidine
The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body. Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan. A urine sample may be collected at the end of the imaging of the tracer compound to analyze its breakdown products.
Other Names:
  • PET Scan
  • Outcome Measures

    Primary Outcome Measures

    1. Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs [at time of PET or CT PET Scan]

    2. Changes in thymidine kinase, thymidylate synthase, and standardized uptake values [before and after therapy]

    Secondary Outcome Measures

    1. FLT PET response rate [up to 2 hours during PET scan]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Meets one of the following criteria:

    • Histologically confirmed solid tumor or hematologic malignancy

    • Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging

    PATIENT CHARACTERISTICS:
    • Able to lie still in the PET scanner

    • Girth and weight must be suitable to enter the gantry

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Anthony F. Shields, MD, PhD, Barbara Ann Karmanos Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00935090
    Other Study ID Numbers:
    • 2006-127
    • P30CA022453
    • WSU-2006-127
    First Posted:
    Jul 8, 2009
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022