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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Anthony Shields, Barbara Ann Karmanos Cancer Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anthony Shields, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00935090
First received: July 7, 2009
Last updated: March 29, 2017
Last verified: March 2017
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Anthony Shields, Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935090

Locations
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: Patricia LoRusso, D.O.         
Sub-Investigator: Elisabeth Heath, M.D.         
Sub-Investigator: Muaiad Kittaneh, M.D.         
Sub-Investigator: Ajay Kumar, Ph.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.         
Sub-Investigator: Anteneh Tesfaye, M.D.         
Sub-Investigator: Manish Thakur, M.S.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Anthony Shields, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov 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 )
PFIZER-WSU-2006-127
Study First Received: July 7, 2009
Last Updated: March 29, 2017

Keywords provided by Anthony Shields, Barbara Ann Karmanos Cancer Institute:
myelodysplastic/myeloproliferative neoplasm, unclassifiable
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:
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Lymphoma
Disease
Syndrome
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Nervous System Neoplasms
Central Nervous System Neoplasms
Plasmacytoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site

ClinicalTrials.gov processed this record on August 21, 2017