Clinical trial NCT00256490: Early Evaluation of the Response of Large B Cell Non Hodgkin's Lymphoma to Chemotherapy by PET/CT
Official title: Early Evaluation of the Response of Large B Cell Non Hodgkin's Lymphoma to Chemotherapy by Positron Emission Tomography Coupled With Computed Tomography (PET/CT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Large-Cell
Keywords: Diffuse large B cells lymphoma
PET/CT
FDG
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients affected with non-Hodgkin's large B-cell lymphoma are treated by chemotherapy. The evaluation of the response to this treatment is made by Positron Emission Tomography (PET/CT) in many centres where this technology is available. Presently PET scans and CT scans are being performed before treatment, after 4 cycles of chemotherapy and a few months after the end of treatment.

The goal of this study is to determine if it is possible to evaluate the efficiency of chemotherapy treatments after one cycle of treatment instead of waiting after 4 cycles, using a new scanner that combines PET and CT modalities. Data available from studies on these combined exams suggest that PET/CT helps to rapidly evaluate the response of the chemotherapy treatment. We also want to verify if some pathological characteristics measured from tumor cells will enable doctors to predict in advance the response to treatment.

Detailed description: Participation in this study involves 4 PET/CT exams, which occur before the treatments start, after the first cycle of chemotherapy, after 4 cycles of chemotherapy and then 12 weeks after the end of the treatments. The only additional test performed in this study compared to the regular follow-up of patients that are not in this study is the PET/CT exam after the first cycle. Your participation in this study will not affect treatment since the results of the first PET/CT test will not be communicated. All other tests results will be available in the medical record.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed large B cells non Hodgkin's lymphoma, CD20 positive
* Chemotherapy treatments planned (R-CHOP) but not started

Exclusion Criteria:

* Pregnancy (determined by urinary β-HCG and blood test)
* Patients younger than 18 years
* Unable to tolerate the procedure (30 minutes laying down on the back)
* No chemotherapy treatment planned secondary to the patient's health performance
* Previous lymphoma that has been treated with chemotherapy with the exception of stade I lymphoma treated only with radiotherapy.
* All lymphoma other than large cell Non Hodgkin's lymphoma

Primary outcomes:
measure: Disease free survival at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Eric Turcotte, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Francois Bénard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Virginie Bruneau, MD
role: PRINCIPAL_INVESTIGATOR
References: