F18-FLT PET/CT as a Tool for Assessment of Myeloablative... | NCT01592266

Studies
F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)

NCT01592266

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

May 7, 2012Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Acute Myeloid Leucemia

Interventions

Not provided

Countries

Israel

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

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2013Estimated

Completion Date

Not provided

First Submitted Date

Apr 16, 2012

First Submission Date that Met QC Criteria

May 3, 2012

First Posted Date

May 7, 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

May 3, 2012

Last Update Posted Date

May 7, 2012Estimated

Description Module

Brief Summary

PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution. Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic disease either in bone marrow or extramedullary.

F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive study can replace bone marrow biopsy and predict response vs. non response to therapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
AML		patients with AML prior and after treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of extent and intensity ( by standardized uptake value - SUV) of disease in bone marrow demonstrated on PET/CT images before and after treatment.

Secondary Outcomes

Measure	Description	Time Frame
prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

new diagnosis of AML

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with new diagnosis of AML

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marina Orevi, MD	Contact			marinaor@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Hebrew University Medical Center		Jerusalem			Israel