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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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
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

Other trials in United States

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.

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 groups in NCT00935090
Study groupRoleWhat they receive
3'-deoxy-3'-[18F]fluorothymidineExperimentalThe 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.

  1. 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

  2. Changes in thymidine kinase, thymidylate synthase, and standardized uptake values

    Measured: before and after therapy

Secondary outcomes (1)
  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.

  1. First posted8 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completion4 Apr 2024
  4. Study completion4 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
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

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