FLT-PET Imaging for MDS
This study is currently recruiting participants.
Verified October 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01535456
First received: February 14, 2012
Last updated: October 8, 2012
Last verified: October 2012
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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 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
To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy
Secondary objectives
- To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
- 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
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: | October 8, 2012 |
| 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 May 23, 2013