The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT01865058|
Recruitment Status : Unknown
Verified May 2013 by Karen Juul Mylam, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment.
This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.
|Condition or disease|
|Diffuse Large B-cell Lymphoma|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||August 2014|
Patients with newly diagnosis of diffuse large B-cell lymphoma is offered enrollment in this protocol.
- Progression free survival [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 2 years, 3 years ]
- Treatment response (CR, PR, PD) [ Time Frame: Up to 24 weeks ]The time frame is from baseline PET scanning to completions of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865058
|Contact: Karen Juul Mylam, MD||0045 6541 firstname.lastname@example.org|
|Hematology Rearch Unit, Odense University Hospital||Recruiting|
|Odense, Fyn, Denmark, 500|
|Contact: Karen Juul Mylam, MD email@example.com|
|Principal Investigator: Karen Juul Mylam, MD|
|Principal Investigator:||Karen Juul Mylam, MD||Hematology research Unit, Odense University Hospital|