Clinical trial · Observational
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
NCT00915096CI-TRIAL-00034530completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- High Tumor Burden Follicular Lymphoma
Primary outcomes (1)
- measure
- Predictive value of PET on progression-free survival
- timeFrame
- 2 years
Secondary outcomes (6)
- measure
- Comparison of PET results to treatment response (Cheson criteria)
- timeFrame
- 30 weeks
- measure
- Correlation of PET data with FLIPI index score
- timeFrame
- Baseline
- measure
- Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDupuis 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 23109699