NCT01592266

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

May 7, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

April 16, 2012

Last Update Submit

May 3, 2012

Conditions

Keywords

FLTPETbone marrowAML

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy

Study Arms (1)

AML

patients with AML prior and after treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with new diagnosis of AML

You may qualify if:

  • new diagnosis of AML

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, Israel

Location

Central Study Contacts

Marina Orevi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

May 7, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Last Updated

May 7, 2012

Record last verified: 2012-04

Locations