Brain and Central Nervous System TumorsNCT00935090
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
A study testing 3'-deoxy-3'-[18F]fluorothymidine in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- What is being tested?
- 3'-deoxy-3'-[18F]fluorothymidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 4 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Use of [F-18] FLT for Imaging With Positron Emission Tomography (PET)
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- 3'-deoxy-3'-[18F]fluorothymidine
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3'-deoxy-3'-[18F]fluorothymidineDevice
Also called PET Scan
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.
| Study group | Role | What they receive |
|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Experimental | The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body. Receives: Device: 3'-deoxy-3'-[18F]fluorothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs
Measured: at time of PET or CT PET Scan
Changes in thymidine kinase, thymidylate synthase, and standardized uptake values
Measured: before and after therapy
Secondary outcomes (1)
FLT PET response rate
Measured: up to 2 hours during PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startSep 2009
- Primary completion4 Apr 2024
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute
- Investigators
- Anthony F. Shields, MD, PhD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935090
- Sponsor's protocol ID
- 2006-127
- Other IDs
- P30CA022453, WSU-2006-127
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2009
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes