Lymphoma, Large-CellNCT00256490
Early Evaluation of the Response of Large B Cell Non Hodgkin's Lymphoma to Chemotherapy by PET/CT
A study testing PET/CT 20 days after the first cycle of chemotherapy in people with Lymphoma, Large-Cell, run by Eric Turcotte at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Large-Cell
- What is being tested?
- PET/CT 20 days after the first cycle of chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to 1 Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed large B cells non Hodgkin's lymphoma, CD20 positive
- Chemotherapy treatments planned (R-CHOP) but not started
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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)
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.
Read the 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.
- Conditions
- Lymphoma, Large-Cell
- Being tested
- PET/CT 20 days after the first cycle of chemotherapy
- Keywords
- Diffuse large B cells lymphoma, PET/CT, FDG
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT 20 days after the first cycle of chemotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Turcotte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Turcotte, Université de Sherbrooke
- Investigators
- Eric Turcotte, MD, FRCPC, Principal investigator, Centre de recherche du Centre hospitalier universitaire de SherbrookeFrancois Bénard, MD, FRCPC, Principal investigator, Centre de recherche du Centre hospitalier universitaire de SherbrookeVirginie Bruneau, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256490
- Sponsor's protocol ID
- CRC 05-020
- Other IDs
- CIMF 2005-01
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2005
- Last updated
- 9 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00256490
- Acronym / sponsor ID
- CRC 05-020
- Conditions
- Lymphoma, Large-Cell
- Keywords
- Diffuse large B cells lymphoma, PET/CT, FDG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Eric TurcotteUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed large B cells non Hodgkin's lymphoma, CD20 positive
- Chemotherapy treatments planned (R-CHOP) but not started
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT 20 days after the first cycle of chemotherapy | Procedure or surgery | – |
Primary outcome
Disease free survival at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Turcotte, MD, FRCPC principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Francois Bénard, MD, FRCPC principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Virginie Bruneau, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT 20 days after the first cycle of chemotherapy in people with Lymphoma, Large-Cell, run by Eric Turcotte at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival at 2 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.