FLT-PET Imaging for MDS

This study is currently recruiting participants.

Verified October 2012 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: October 8, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2012

Last Updated Date

October 8, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01535456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

FLT-PET Imaging for MDS

Official Title ^ICMJE

A Pilot Study for Using 18F-FLT PET Imaging To Assess Response In Patients With Myelodysplastic Syndrome (MDS) Being Treated With 5-azacitidine

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Procedure: FLT-PET scans

FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4

Study Arm (s)

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.

Intervention: Procedure: FLT-PET scans

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01535456

Other Study ID Numbers ^ICMJE

HO10417

Has Data Monitoring Committee

Yes

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ryan J Mattison, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top