FLT-PET Imaging for MDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535456
Recruitment Status : Terminated (funding)
First Posted : February 17, 2012
Last Update Posted : April 30, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.

Condition or disease Intervention/treatment Phase
AML MDS Procedure: FLT-PET scans Not Applicable

Detailed Description:

Primary objectives

  1. To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy

    Secondary objectives

  2. To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
  3. To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
Drug Information available for: Azacitidine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: F-FLT PET scan, 5-azacitidine treatment
F-FLT Pet scan followed by 5-azacitidine treatment followed by FLT-PET scan. Three additional cycles of 5-azacytidine and follow up FLT-PET scan.
Procedure: FLT-PET scans
FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4

Primary Outcome Measures :
  1. feasibility of using FLT-PET to assess chemotherapy response in AML/MDS [ Time Frame: 3 years ]
    This pilot study is intended to investigate the feasibility of FLT-PET for early assessment of treatment response in myelodysplastic syndrome and the use of a PET isotope, (18)F-FLT, in the imaging of bone marrow in subjects with MDS. The objectives will help gather initial information for a future, larger, more definitive study.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26.
  • Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
  • The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
  • Subjects must have an ECOG performance status of 0, 1, or 2
  • Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
  • Subjects must be > 18 years of age
  • Subjects must have a serum creatinine < 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
  • Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
  • Women must not be pregnant nor breastfeeding
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception

Exclusion Criteria:

  • Subjects who are pregnant or breast feeding
  • Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.

    • Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535456

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Ryan J Mattison, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT01535456     History of Changes
Other Study ID Numbers: HO10417
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by University of Wisconsin, Madison:
5 azacitidine

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors