Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

Conditions
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Lymphoma, Follicular

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Tumor Burden Follicular Lymphoma<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of PET on progression-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Comparison of conventional criteria for evaluating the response to the criteria revised by the international workshop criteria |  | 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Lymphoma, PET, GELA