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

Overview

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.

Full Title of Study: “Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

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.

Interventions

  • 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 Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan.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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of the uptake and retention of 3′-deoxy-3′-[18F] fluorothymidine (FLT) in tumors and normal organs
    • Time Frame: at time of PET or CT PET Scan
  • Changes in thymidine kinase, thymidylate synthase, and standardized uptake values
    • Time Frame: before and after therapy

Secondary Measures

  • FLT PET response rate
    • Time Frame: up to 2 hours during PET scan

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Barbara Ann Karmanos Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anthony F. Shields, MD PhD, Principal Investigator – Barbara Ann Karmanos Cancer Institute
  • Overall Official(s)
    • Anthony F. Shields, MD, PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute

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