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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
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Karen Juul Mylam, Odense University Hospital

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
DLBCL
Patients with newly diagnosis of diffuse large B-cell lymphoma is offered enrollment in this protocol.



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
  2. Progression free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years, 3 years ]

Other Outcome Measures:
  1. Treatment response (CR, PR, PD) [ Time Frame: Up to 24 weeks ]
    The time frame is from baseline PET scanning to completions of therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosis of Diffuse Large B-cell lymphoma
Criteria

Inclusion Criteria:

-Age>18 years

Exclusion Criteria:

  • Previously treatment with chemotherapy or irradiation
  • Primary CNS lymphoma
  • Recurrent lymphoma
  • Transformation from indolent lymphoma
  • Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
  • Planned for curative treatment

Information from the National Library of Medicine

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


Contacts
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Contact: Karen Juul Mylam, MD 0045 6541 1637 karen.mylam@rsyd.dk

Locations
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Denmark
Hematology Rearch Unit, Odense University Hospital Recruiting
Odense, Fyn, Denmark, 500
Contact: Karen Juul Mylam, MD       karen.mylam@rsyd.dk   
Principal Investigator: Karen Juul Mylam, MD         
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
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Principal Investigator: Karen Juul Mylam, MD Hematology research Unit, Odense University Hospital

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Responsible Party: Karen Juul Mylam, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01865058    
Other Study ID Numbers: DLG-PET 10.06
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin