Early Evaluation of the Response of Large B Cell Non Hodgkin’s Lymphoma to Chemotherapy by PET/CT

Lymphoma, Large-Cell Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00256490
• Other study ID #: CRC 05-020
• Secondary ID: CIMF 2005-01
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2005
• Last updated: November 17, 2005
• Start date: November 2005
• Est. completion date: November 2009

Study information

• Verified date: November 2005
• Source: Université de Sherbrooke
• Contact: Eric Turcotte, MD, FRCPC
• Phone: 819-346-1110
• Email: e.turcotte[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large-Cell
• Lymphoma, Non-Hodgkin

Intervention

Procedure:
• PET/CT 20 days after the first cycle of chemotherapy

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival at 2 years