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 : Unknown
Verified March 2010 by Lymphoma Study Association.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2009
Last Update Posted : March 16, 2010
Information provided by:
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

Study Type : Observational
Estimated Enrollment : 120 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
Study Start Date : September 2007
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

CHU - Besançon
Besançon, France
CHU Avicenne
Bobigny, France
Centre Bergognié
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France, 21034
Clinique Victor Hugo
Le Mans, France
Centre Hospitalier - Lens
Lens, France
CHRU Lille
Lille, France, 59037
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 Benite, France, 69310
CHU Robert Debré
Reims, France
Centre Henri Becquerel
Rouen, France, 76038
CHU Purpan
Toulouse, France
Hôpital Bretonneau
Tours, France
CHU Brabois
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France
Ospedale Cuneo
Cuneo, Italy
Sponsors and Collaborators
Lymphoma Study Association
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):
Responsible Party: Prof. Michel MEIGNAN, CHU Henri MONDOR Identifier: NCT00915096     History of Changes
Other Study ID Numbers: PET-FOL
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010

Keywords provided by Lymphoma Study Association:
Follicular Lymphoma

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin