FLT-PET Imaging for MDS

AML Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535456
• Other study ID #: HO10417
• Secondary ID: A534260SMPH\MEDI
• Status: Terminated
• Phase: N/A
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• AML
• MDS

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of using FLT-PET to assess chemotherapy response in AML/MDS	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.	3 years