Early Evaluation of the Response of Large B Cell Non Hodg... | NCT00256490

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

NCT00256490

Sponsor

Eric Turcotte

Status

Completed

Last Update Posted

Dec 9, 2024Actual

Enrollment

82Estimated

Phase

Not Applicable

Conditions

Lymphoma, Large-Cell

Interventions

PET/CT 20 days after the first cycle of chemotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIMF 2005-01

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005Actual

Primary Completion Date

Dec 1, 2009Actual

Completion Date

Dec 1, 2009Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Name	Type	Description	Arm Group Labels	Other Names
PET/CT 20 days after the first cycle of chemotherapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease free survival at 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Sherbrooke		Sherbrooke	Quebec	J1H 5N4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D054739	Dendritic Cell Sarcoma, Interdigitating

Ancestor Terms

ID	Term
D015620	Histiocytic Disorders, Malignant
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D015614	Histiocytosis

Browse Leaves

Not provided

Browse Branches

Not provided