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

Primary Purpose

Lymphoma, Large-Cell

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

PET/CT 20 days after the first cycle of chemotherapy

About this trial

This is an interventional diagnostic trial for Lymphoma, Large-Cell focused on measuring Diffuse large B cells lymphoma, PET/CT, FDG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire de SherbrookeRecruiting

Outcomes

Primary Outcome Measures

Disease free survival at 2 years

Secondary Outcome Measures

Full Information

NCT ID

NCT00256490

First Posted

November 17, 2005

Last Updated

November 17, 2005

Sponsor

Université de Sherbrooke

1. Study Identification

Unique Protocol Identification Number

NCT00256490

Brief Title

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

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Unknown status

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Université de Sherbrooke

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Large-Cell

Keywords

Diffuse large B cells lymphoma, PET/CT, FDG

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

82 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

PET/CT 20 days after the first cycle of chemotherapy

Primary Outcome Measure Information:

Title

Disease free survival at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Turcotte, MD, FRCPC

Phone

819-346-1110

Ext

11887

e.turcotte@usherbrooke.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Chantal Langevin, inf

Phone

819-346-1110

Ext

12887

chantal.langevin@chus.qc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Turcotte, MD, FRCPC

Organizational Affiliation

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francois Bénard, MD, FRCPC

Organizational Affiliation

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Virginie Bruneau, MD

Organizational Affiliation

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire de Sherbrooke

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Turcotte, MD, FRCPC

Phone

819-346-1110

Ext

11887

e.turcotte@usherbrooke.ca

12. IPD Sharing Statement

Learn more about this trial

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

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