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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00935090
Recruitment Status : Recruiting
First Posted : July 8, 2009
Last Update Posted : February 12, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Detailed Description:



  • 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.


  • 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Study Start Date : September 2009
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Myelodysplastic Syndromes Acute Lymphoblastic Leukemia B-cell Lymphoma Mantle Cell Lymphoma Chronic Myeloid Leukemia Diffuse Large B-Cell Lymphoma Multiple Myeloma Hodgkin Lymphoma Mycosis Fungoides Cutaneous T-cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Marginal Zone Lymphoma Leukemia, T-cell, Chronic Essential Thrombocythemia Burkitt Lymphoma Waldenstrom Macroglobulinemia Lymphoblastic Lymphoma Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Hairy Cell Leukemia Extranodal Nasal NK/T Cell Lymphoma Lymphoma, Large-cell Anaplastic Large Cell Lymphoma Myelofibrosis Polycythemia Vera Aggressive NK Cell Leukemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Sezary Syndrome AL Amyloidosis Post-transplant Lymphoproliferative Disease Plasmacytoma Adult T-cell Leukemia/lymphoma Large Granular Lymphocyte Leukemia Lymphomatoid Granulomatosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia

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 Name: PET Scan

Primary Outcome Measures :
  1. 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 ]
  2. Changes in thymidine kinase, thymidylate synthase, and standardized uptake values [ Time Frame: before and after therapy ]

Secondary Outcome Measures :
  1. FLT PET response rate [ Time Frame: up to 2 hours during PET scan ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00935090

United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    800-527-6266      
Sub-Investigator: Shirish Gadgeel, M. D.         
Sub-Investigator: Ulka Vaishampayan, M.D.         
Sub-Investigator: Antoinette Wozniak, M.D.         
Sub-Investigator: Elisabeth Heath, M.D.         
Sub-Investigator: Laurel E. Stroempl, PA         
Sub-Investigator: Otto Muzik, Ph.D.         
Sub-Investigator: Lance Heilbrun, Ph.D.         
Sub-Investigator: Thomas Mangner, Ph.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute

Additional Information:
Responsible Party: Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00935090     History of Changes
Other Study ID Numbers: CDR0000647210
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-127 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Keywords provided by Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute:
Waldenstrom macroglobulinemia
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Nervous System Neoplasms
Central Nervous System Neoplasms
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site