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NCT00935090 Clinical Trial

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

Lymphoma Clinical Trial

Official title:
Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00935090
Other study ID # 2006-127
Secondary ID P30CA022453WSU-2
Status Suspended
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date January 2024

Study information
Verified date May 2023
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 80
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Brain and Central Nervous System Tumors
  • Central Nervous System Neoplasms
  • Chronic Myeloproliferative Disorders
  • Disease
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Nervous System Neoplasms
  • Plasmacytoma
  • Preleukemia
  • Syndrome
  • Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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.

Locations
Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan

Sponsors (2)
Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Changes in thymidine kinase, thymidylate synthase, and standardized uptake values before and after therapy
Secondary FLT PET response rate up to 2 hours during PET scan
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