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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915096
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : August 23, 2018
Information provided by (Responsible Party):
Lymphoma Study Association

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.

Condition or disease
Lymphoma, Follicular

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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
Actual Study Start Date : September 18, 2007
Actual Primary Completion Date : May 10, 2011
Actual Study Completion Date : February 8, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

High Tumor Burden Follicular Lymphoma

Primary Outcome Measures :
  1. Predictive value of PET on progression-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Comparison of PET results to treatment response (Cheson criteria) [ Time Frame: 30 weeks ]
  2. Correlation of PET data with FLIPI index score [ Time Frame: Baseline ]
  3. Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation [ Time Frame: 30 weeks ]
  4. Correlation of PET data with histopathological data (including the use of immunohistochemical markers) [ Time Frame: Baseline ]
  5. Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow [ Time Frame: Baseline ]
  6. Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria [ Time Frame: 30 weeks ]

Biospecimen Retention:   Samples With DNA
Burden tissue sample

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High Tumor Burden Follicular Lymphoma patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00915096

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Sponsors and Collaborators
Lymphoma Study Association
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Principal Investigator: Michel MEIGNAN, Prof Lymphoma Study Association
Principal Investigator: Jehan DUPUIS, MD Lymphoma Study Association
Additional Information:
GELA  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lymphoma Study Association Identifier: NCT00915096    
Other Study ID Numbers: PET-FOL
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Keywords provided by Lymphoma Study Association:
Follicular Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin