- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915096
Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
August 21, 2018 updated by: Lymphoma Study Association
High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
121
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
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Besançon, France
- CHU - Besançon
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Bobigny, France
- CHU Avicenne
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Bordeaux, France
- Centre Bergognié
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Créteil, France
- Hôpital Henri Mondor
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Dijon, France, 21034
- CHU de DIJON
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Le Mans, France
- Clinique Victor Hugo
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Lens, France
- Centre Hospitalier - Lens
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Lille, France, 59037
- CHRU Lille
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Limoges, France
- CHU - Limoges
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Marseille, France
- Centre Paoli-Calmettes
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Nantes, France
- CHU - Nantes
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Paris, France
- Hôpital Pitié-Salpétrière
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Paris, France
- Hopital Saint-Louis
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Paris, France
- Hôpital Necker
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Pierre Benite, France, 69310
- CHU Lyon Sud
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Reims, France
- CHU Robert Debré
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Rouen, France, 76038
- Centre Henri Becquerel
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Toulouse, France
- CHU Purpan
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Tours, France
- Hôpital Bretonneau
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Vandoeuvre les Nancy, France, 54511
- Chu Brabois
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Villejuif, France
- Institut Gustave Roussy
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Cuneo, Italy
- Ospedale Cuneo
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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 to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
High Tumor Burden Follicular Lymphoma patients
Description
Inclusion Criteria:
- Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
- Patients who have not previously been treated for this disease,
- Introducing one of the criteria for high tumor burden,
- Patients aged over 18 and under 80 years,
- Patients whose ECOG condition is ≤ 2,
- Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
- Patient had the PET examination less than a month before the start of chemotherapy.
Exclusion Criteria:
- Patients with lymphoma who have already transformed or been treated for this disease,
- Patients whose lymphoma is stage 3b,
- Patients with impaired central nervous system,
- Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
- Patients who have undergone major surgery during the 28 days preceding the inclusion,
- Patients with low kidney and/or liver function,
- Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
- Patients whose life expectancy ≤ 6 months,
- Patients sensitive or allergic to murine products,
- Patients who participated in another clinical trial during the 30 days preceding the recording,
- Patients with other medical problems or psychological succeptibles interfere with the study,
- Patients under adult supervision.
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
Cohorts and Interventions
Group / Cohort |
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High Tumor Burden Follicular Lymphoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Predictive value of PET on progression-free survival
Time Frame: 2 years
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of PET results to treatment response (Cheson criteria)
Time Frame: 30 weeks
|
30 weeks
|
Correlation of PET data with FLIPI index score
Time Frame: Baseline
|
Baseline
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Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation
Time Frame: 30 weeks
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30 weeks
|
Correlation of PET data with histopathological data (including the use of immunohistochemical markers)
Time Frame: Baseline
|
Baseline
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Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow
Time Frame: Baseline
|
Baseline
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Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria
Time Frame: 30 weeks
|
30 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel MEIGNAN, Prof, Lymphoma Study Association
- Principal Investigator: Jehan DUPUIS, MD, Lymphoma Study Association
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
September 18, 2007
Primary Completion (ACTUAL)
May 10, 2011
Study Completion (ACTUAL)
February 8, 2013
Study Registration Dates
First Submitted
June 4, 2009
First Submitted That Met QC Criteria
June 4, 2009
First Posted (ESTIMATE)
June 5, 2009
Study Record Updates
Last Update Posted (ACTUAL)
August 23, 2018
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET-FOL
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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