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 : December 7, 2017
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|
|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|
- 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 :||September 2018|
|Estimated Study Completion Date :||September 2018|
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 Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan.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 ]
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: 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.|
|Principal Investigator:||Anthony F. Shields, MD, PhD||Barbara Ann Karmanos Cancer Institute|