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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01592266
Other study ID # 0112-12-HMO
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 16, 2012
Last updated May 3, 2012
Start date October 2012

Study information

Verified date April 2012
Source Hadassah Medical Organization
Contact Marina Orevi, MD
Email marinaor@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- new diagnosis of AML

Exclusion Criteria:

- pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Israel Hadassah Hebrew University Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy