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

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ClinicalTrials.gov Identifier: NCT01599429
Recruitment Status : Unknown
Verified September 2014 by Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
Recruitment status was:  Recruiting
First Posted : May 16, 2012
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:

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.


Condition or disease
Acute Myeloid Leukemia

Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of FLT-TEP Scan as Predictive Marker and Early Prognostic in Patients Suffering From AML Treated by Chemotherapy
Study Start Date : October 2011
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : October 2015





Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599429


Contacts
Contact: Annie Morin, MSc 819-346-1110 ext 16359 amorin.chus@ssss.gouv.qc.ca
Contact: Anick Champoux, Infirmière 819-346-1110 ext 12811 achampoux.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Annie Morin, MSc    819-346-1110 ext 16359    amorin.chus@ssss.gouv.qc.ca   
Contact: Anick Champoux, Infirmière    819-346-1110 ext 12811    achampoux.chus@ssss.gouv.qc.ca   
Sub-Investigator: Hans Knecht, MD         
Sub-Investigator: Jean-François Castilloux, MD         
Sub-Investigator: Mariette Lépine, MD         
Sub-Investigator: Patrice Beauregard, MD         
Principal Investigator: Rami Kotb, MD         
Principal Investigator: Éric E Turcotte, MD         
Sponsors and Collaborators
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

Responsible Party: Dr Éric E Turcotte, MD, Principal Investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01599429     History of Changes
Other Study ID Numbers: CIMS-2011-01
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
AML / LMA

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