- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00256490
Early Evaluation of the Response of Large B Cell Non Hodgkin's Lymphoma to Chemotherapy by PET/CT
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Disease free survival at 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Turcotte, MD, FRCPC, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
- Principal Investigator: Francois Bénard, MD, FRCPC, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
- Principal Investigator: Virginie Bruneau, MD, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC 05-020
- CIMF 2005-01
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