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

This study is not yet open for participant recruitment.
Verified April 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01592266
First received: April 16, 2012
Last updated: May 3, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Acute Myeloid Leucemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With AML

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AML
patients with AML prior and after treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with new diagnosis of AML

Criteria

Inclusion Criteria:

  • new diagnosis of AML

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592266

Contacts
Contact: Marina Orevi, MD marinaor@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel
Principal Investigator: Marina Orevi, MD            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01592266     History of Changes
Other Study ID Numbers: 0112-12-HMO
Study First Received: April 16, 2012
Last Updated: May 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
FLT
PET
bone marrow
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013