FLT-PET Imaging for MDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01535456
First received: February 14, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention
AML
MDS
Procedure: FLT-PET scans

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • feasibility of using FLT-PET to assess chemotherapy response in AML/MDS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535456

Contacts
Contact: Ryan J Mattison, MD 608-262-5697 rjmattison@medicine.wisc.edu
Contact: Erica A Barnstable 608-263-1974 eab@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Ryan J Mattison, M.D.    608-262-5697    rjmattison@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Ryan J Mattison, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01535456     History of Changes
Other Study ID Numbers: HO10417
Study First Received: February 14, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
MDS
AML
5 azacitidine
FLT PET

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014