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 : April 1, 2022
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|
- 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)|
|Official Title:||Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||February 9, 2023|
|Estimated Study Completion Date :||December 2023|
The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body.
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 Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan.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
- 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 ]
- FLT PET response rate [ Time Frame: up to 2 hours during PET scan ]
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
|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: Elisabeth Heath, M.D.|
|Sub-Investigator: Laurel E. Stroempl, PA|
|Sub-Investigator: Otto Muzik, Ph.D.|
|Sub-Investigator: Thomas Mangner, Ph.D.|
|Sub-Investigator: Mohammed Najeep Al Hallak, M.D|
|Sub-Investigator: Hirva Mamdani, M.D|
|Sub-Investigator: Ammar Sukari, M.D.|
|Principal Investigator:||Anthony F. Shields, MD, PhD||Barbara Ann Karmanos Cancer Institute|