NCT00256490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

November 17, 2005

Last Update Submit

December 4, 2024

Conditions

Keywords

Diffuse large B cells lymphomaPET/CTFDG

Outcome Measures

Primary Outcomes (1)

  • Disease free survival at 2 years

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed large B cells non Hodgkin's lymphoma, CD20 positive
  • Chemotherapy treatments planned (R-CHOP) but not started

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations