A Study of F-fluro-3'deoxy-3-D-fluorothymidine with PET/CT Scanning to Measure Treatment Response in Patients with Previously Untreated Acute Myeloid Leukemia

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-009381
    NCT ID: NCT02392429
    Sponsor Protocol Number: EAI141

About this study

This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring treatment response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Must have previously untreated AML and be candidates for intensive induction chemotherapy
  • Are allowed to have had prior hydroxyurea
  • Must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)
  • Must have left ventricular ejection fraction (LVEF) > 45% or within institutional normal limits
  • Must be able to lie still for a 1.5 hour PET scan
  • Must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine
  • Must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center
  • Is participating in the trial at an institution which has agreed to perform the imaging research studies, complete the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and receive ECOG-ACRIN approval as outlined
  • Must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria
      • Has not undergone a hysterectomy or bilateral oophorectomy
      • Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kebede Begna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20260181

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