Acute Myeloid LeukemiaTEP-FLT-LMANCT01599429
Study of the Predictive Marker FLT in Patients Suffering From AML
An observational study of Acute Myeloid Leukemia, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2011to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients newly diagnosed with acute myeloid, between October 2011 and October 2013, at the Centre Hospitalier Universitaire de Sherbrooke (CHUS).
Who may be able to join
- Patients 18 years or above at the time of inclusion;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 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.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML / LMA
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
To mesure the pronostic value of metabolic activity in the bone marrow with FLT-PET prior to chemotherapy in patients with AML disease.
Measured: September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study start31 Oct 2011
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Investigators
- Éric E Turcotte, MD, Principal investigator, Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke, Centre d'imagerie moléculaire de Sherbrooke (CIMS), Centre de recherche Étienne Le-BelRami Kotb, MD, Principal investigator, Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599429
- Sponsor's protocol ID
- CIMS-2011-01
- Acronym
- TEP-FLT-LMA
- Status last verified
- Apr 2021
- First submitted
- 4 Nov 2011
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of FLT-TEP Scan as Predictive Marker and Early Prognostic in Patients Suffering From AML Treated by Chemotherapy
- ClinicalTrials.gov ID
- NCT01599429
- Acronym / sponsor ID
- TEP-FLT-LMA / CIMS-2011-01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML / LMA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 31 Oct 2011
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with acute myeloid, between October 2011 and October 2013, at the Centre Hospitalier Universitaire de Sherbrooke (CHUS).
Key inclusion criteria (4 listed)
- Patients 18 years or above at the time of inclusion;
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Éric E Turcotte, MD principal investigator
Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke, Centre d'imagerie moléculaire de Sherbrooke (CIMS), Centre de recherche Étienne Le-Bel
Rami Kotb, MD principal investigator
Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.