Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Université de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00256490
First received: November 17, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Lymphoma, Large-Cell
Procedure: PET/CT 20 days after the first cycle of chemotherapy

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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Disease free survival at 2 years

Estimated Enrollment: 82
Study Start Date: November 2005
Estimated Study Completion Date: November 2009
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256490

Contacts
Contact: Eric Turcotte, MD, FRCPC 819-346-1110 ext 11887 e.turcotte@usherbrooke.ca
Contact: Chantal Langevin, inf 819-346-1110 ext 12887 chantal.langevin@chus.qc.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Eric Turcotte, MD, FRCPC    819-346-1110 ext 11887    e.turcotte@usherbrooke.ca   
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Eric Turcotte, MD, FRCPC Centre Hospitalier Universitaire de Sherbrooke
Principal Investigator: Francois Bénard, MD, FRCPC Centre Hospitalier Universitaire de Sherbrooke
Principal Investigator: Virginie Bruneau, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00256490     History of Changes
Other Study ID Numbers: CRC 05-020, CIMF 2005-01
Study First Received: November 17, 2005
Last Updated: November 17, 2005
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Diffuse large B cells lymphoma
PET/CT
FDG

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014