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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935090
Recruitment Status : Suspended (The Investigator is negotiating with other company to use FLT PET)
First Posted : July 8, 2009
Last Update Posted : May 6, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute

Study Description
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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:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
Actual Study Start Date : September 2009
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00935090


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
More Information
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Additional Information:

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Responsible Party: Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00935090    
Other Study ID Numbers: 2006-127
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: May 6, 2023
Last Verified: May 2023
Keywords provided by Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute:
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
stage III adult T-cell leukemia/lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Nervous System Neoplasms
Central Nervous System Neoplasms
Plasmacytoma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Syndrome
 Pathologic Processes
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site