Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
1 other identifier
observational
121
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2007
CompletedFirst Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2013
CompletedAugust 23, 2018
August 1, 2018
3.6 years
June 4, 2009
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predictive value of PET on progression-free survival
2 years
Secondary Outcomes (6)
Comparison of PET results to treatment response (Cheson criteria)
30 weeks
Correlation of PET data with FLIPI index score
Baseline
Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation
30 weeks
Correlation of PET data with histopathological data (including the use of immunohistochemical markers)
Baseline
Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow
Baseline
- +1 more secondary outcomes
Study Arms (1)
High Tumor Burden Follicular Lymphoma
Eligibility Criteria
High Tumor Burden Follicular Lymphoma patients
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
CHU - Besançon
Besançon, France
CHU Avicenne
Bobigny, France
Centre Bergognié
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
CHU de Dijon
Dijon, 21034, France
Clinique Victor Hugo
Le Mans, France
Centre Hospitalier - Lens
Lens, France
CHRU Lille
Lille, 59037, France
CHU - Limoges
Limoges, France
Centre Paoli-Calmettes
Marseille, France
CHU - Nantes
Nantes, France
Hôpital Necker
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
Hôpital Saint-Louis
Paris, France
CHU Lyon Sud
Pierre-Bénite, 69310, France
CHU Robert Debré
Reims, France
Centre Henri Becquerel
Rouen, 76038, France
CHU Purpan
Toulouse, France
Hôpital Bretonneau
Tours, France
CHU Brabois
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, France
Ospedale Cuneo
Cuneo, Italy
Related Publications (1)
Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.
PMID: 23109699DERIVED
Related Links
Biospecimen
Burden tissue sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel MEIGNAN, Prof
Lymphoma Study Association
- PRINCIPAL INVESTIGATOR
Jehan DUPUIS, MD
Lymphoma Study Association
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 5, 2009
Study Start
September 18, 2007
Primary Completion
May 10, 2011
Study Completion
February 8, 2013
Last Updated
August 23, 2018
Record last verified: 2018-08