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

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ClinicalTrials.gov Identifier: NCT00256490
Recruitment Status : Unknown
Verified November 2005 by Université de Sherbrooke.
Recruitment status was:  Recruiting
First Posted : November 21, 2005
Last Update Posted : November 21, 2005
Sponsor:
Information provided by:
Université de Sherbrooke

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date November 21, 2005
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
Disease free survival at 2 years
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Evaluation of the Response of Large B Cell Non Hodgkin’s Lymphoma to Chemotherapy by PET/CT
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lymphoma, Large-Cell
Intervention  ICMJE Procedure: PET/CT 20 days after the first cycle of chemotherapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: November 17, 2005)
82
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256490
Other Study ID Numbers  ICMJE CRC 05-020
CIMF 2005-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Université de Sherbrooke
Verification Date November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP