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Protocol No. EAI141

Principal Investigator Mattison, Ryan

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title Early Assessment of Treatment Response in AML using FLT PET/CT Imaging

Objective The purpose of this research study is to test if an imaging agent (sometimes also called a tracer), not approved by the Food and Drug Administration (FDA), called FLT, is useful for evaluating your type of cancer in response to standard treatment. This imaging agent is used to perform a PET scan. The researchers want to see if the FLT PET/CT scan, using the study drug, can improve upon the usual way of monitoring your type of cancer in response to standard treatment.

Treatment Standard practice for finding out whether you are responding to your treatment is done through bone marrow biopsy. You will still undergo this procedure. The study will add in imaging to compare its results with study subjects' biopsy results and see if it can betterpredict response to therapy.The experimental part of the imaging study is the agent that will be used with a positron emission tomography/computed tomography (PET/CT) scan. The agent is commonly known as "FLT" (fluorothymidine). It is a radioactive substance that may "light up" where cancer is in your body. The imaging study is called "FLT PET/CT". Standard practice for finding out whether you are responding to your treatment is done through bone marrow biopsy. You will still undergo this procedure. The study will add in imaging to compare its results with study subjects' biopsy results and see if it can better predict response to therapy.

Description If you choose to participate in the study, you will have an optional pre-treatment experimental imaging FLT PET/CT study and all study participants will complete a post-therapy experimental FLT PET/CT imaging study. This study includes laboratory tests that will analyze samples of your bone marrow and/or blood. As part of your clinical care to diagnose and monitor your disease, you will have about one (1) teaspoon of bone marrow aspirate collected prior to the start of treatment and at day 28- 35 (remission). For this study, about one half of this bone marrow sample will be sent for research.

Key Eligibility
  • Patients must have previously untreated AML and be candidates for intensive induction chemotherapy. Patients are allowed to have had prior hydroxyurea.
  • Patients must not have acute promyelocytic leukemia (APL).
  • Patients must be able to lie still for a 1.5 hour PET scan.
  • Women must not be pregnant or breast-feeding.

Applicable Disease Sites Leukemia

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved ara-c (cytarabine); cerubidine (daunorubicin); cytarabine; cytosar (cytarabine); cytosine arabinoside (cytarabine); daunomycin (daunorubicin); daunorubicin; dnm (daunorubicin); id (idarubicin); ida (idarubicin); idamycin (idarubicin); idarubicin; rubidamycin (daunorubicin)

Status Open

Participating Institutions UW Hospital and Clinics