FLT-PET Imaging for MDS | NCT01535456

Studies
FLT-PET Imaging for MDS

NCT01535456

Sponsor

University of Wisconsin, Madison

Status

Terminated

Last Update Posted

Dec 13, 2019Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Interventions

FLT-PET scans

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
A534260	Other Identifier	UW Madison
SMPH\MEDICINE\HEM-ONC	Other Identifier	UW Madison
NCI-2012-00362	Registry Identifier	NCI Trial ID
2011-0285	Other Identifier	Institutional Review Board

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 14, 2012

First Posted Date

Feb 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F-FLT PET scan, 5-azacitidine treatment	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLT-PET scans	Procedure	FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4	F-FLT PET scan, 5-azacitidine treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided