3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
This study is currently recruiting participants.
Verified November 2011 by Barbara Ann Karmanos Cancer Institute
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00935090
First received: July 7, 2009
Last updated: November 1, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | 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 |
Other: 3'-deoxy-3'-[18F]fluorothymidine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET) |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
polycythemia vera
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Nuclear Scans
U.S. FDA Resources
Further study details as provided by 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 [ Designated as safety issue: No ]
- Changes in thymidine kinase, thymidylate synthase, and standardized uptake values before and after therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FLT PET response rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: 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
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 and older |
| Genders Eligible for Study: | Both |
| 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
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 | |
| Sinai-Grace Hospital | Recruiting |
| Detroit, Michigan, United States, 48235 | |
| Contact: Anthony F Shields 313-576-8735 | |
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
| Principal Investigator: | Anthony F. Shields, MD, PhD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Anthony F. Shields, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00935090 History of Changes |
| Other Study ID Numbers: | CDR0000647210, P30CA022453, WSU-2006-127, PFIZER-WSU-2006-127 |
| Study First Received: | July 7, 2009 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
polycythemia vera 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:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Lymphoma, Large-Cell, Immunoblastic Central Nervous System Neoplasms Myelodysplastic-Myeloproliferative Diseases |
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 Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013