Study of the Predictive Marker FLT in Patients Suffering From AML

NCT01599429 | Withdrawn DMC

• 1 other identifier: CIMS-2011-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML / LMA

Outcome Measures

Primary Outcomes (1)

• To mesure the pronostic value of metabolic activity in the bone marrow with FLT-PET prior to chemotherapy in patients with AML disease.

  September 2015

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients newly diagnosed with acute myeloid leukemia;
• No contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3);
• Patients able to give written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: May 16, 2012
• Study Start: October 31, 2011
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

CA (1)