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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 : March 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date March 1, 2021
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2013)
FLT PET response rate [ Time Frame: up to 2 hours during PET scan ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
FLT PET response rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Official Title  ICMJE Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00935090
Other Study ID Numbers  ICMJE CDR0000647210
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-127 ( Other Identifier: Wayne State University - Human Investigation Committee )
PFIZER-WSU-2006-127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date February 2021

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