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

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ClinicalTrials.gov Identifier: NCT00935090
Recruitment Status : Recruiting
First Posted : July 8, 2009
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 7, 2009
July 8, 2009
December 7, 2017
September 2009
September 2018   (Final data collection date for primary outcome measure)
  • 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 ]
  • Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs
  • Changes in thymidine kinase, thymidylate synthase, and standardized uptake values before and after therapy
Complete list of historical versions of study NCT00935090 on ClinicalTrials.gov Archive Site
FLT PET response rate [ Time Frame: up to 2 hours during PET scan ]
FLT PET response rate
Not Provided
Not Provided
 
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)

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.

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.

Interventional
Not Provided
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Unspecified Adult Solid Tumor, Protocol Specific
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 Name: PET Scan
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.
Intervention: Device: 3'-deoxy-3'-[18F]fluorothymidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2018
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
United States
 
 
NCT00935090
CDR0000647210
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-127 ( Other Identifier: Wayne State University - Human Investigation Committee )
PFIZER-WSU-2006-127
Yes
Not Provided
Not Provided
Anthony Shields, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP