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

NCT ID: NCT00256490

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-12-01

Brief Summary

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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

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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.

Conditions

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Lymphoma, Large-Cell

Keywords

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Diffuse large B cells lymphoma PET/CT FDG

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PET/CT 20 days after the first cycle of chemotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eric Turcotte

OTHER

Sponsor Role lead

Responsible Party

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Eric Turcotte

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eric Turcotte, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Francois Bénard, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Virginie Bruneau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CIMF 2005-01

Identifier Type: -

Identifier Source: secondary_id

CRC 05-020

Identifier Type: -

Identifier Source: org_study_id