Study of the Predictive Marker FLT in Patients Suffering From AML (TEP-FLT-LMA)

April 9, 2021 updated by: Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Use of FLT-TEP Scan as Predictive Marker and Early Prognostic in Patients Suffering From AML Treated by Chemotherapy

Positron emission tomography uses various radioactive tracers to measure the metabolic activity in a none-invasive way, and specially to follow the activity of the disease during the treatments.

Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool would allow to image and follow time wise acute myeloid leukemia (AML). The investigators want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic before and after chemotherapy treatment.

The aim of this study is to be able to identify earlier the responders, because if they are detected sooner, these patients will benefit from more aggressive treatments.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients newly diagnosed with acute myeloid, between October 2011 and October 2013, at the Centre Hospitalier Universitaire de Sherbrooke (CHUS).

Description

Inclusion Criteria:

  1. Patients 18 years or above at the time of inclusion;
  2. Patients newly diagnosed with acute myeloid leukemia;
  3. No contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3);
  4. Patients able to give written informed consent.

Exclusion Criteria:

  1. Patients unable to tolerate decubitus position for at least 45 minutes;
  2. Any previous neoplasia or other neoplasia simultaneously;
  3. Previously treated buy radiotherapy, with bone marrow in the field of radiation;
  4. Other chemotherapy treatment than the standard chemotherapy by induction (7+3), before the second FLT-TEP was done.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To mesure the pronostic value of metabolic activity in the bone marrow with FLT-PET prior to chemotherapy in patients with AML disease.
Time Frame: September 2015
September 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Investigators

  • Principal Investigator: Éric E Turcotte, MD, Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke, Centre d'imagerie moléculaire de Sherbrooke (CIMS), Centre de recherche Étienne Le-Bel
  • Principal Investigator: Rami Kotb, MD, Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 31, 2011

Primary Completion (ACTUAL)

October 31, 2017

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

May 14, 2012

First Posted (ESTIMATE)

May 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIMS-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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