Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
Evaluation of Response to Treatment Using 18F-FDG Positron Emission Tomography Imaging (PET) With Special Emphasize on the Prognostic Significance of Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
1 other identifier
observational
100
1 country
1
Brief Summary
Early identification of refractory lymphoma patients provides a basis for stratification between responders to standard approaches and non-responders who may benefit from an early change to an alternative treatment strategy.Metabolic or molecular imaging with fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has emerged as a powerful imaging modality for diagnosis, staging, and therapy monitoring of a variety of cancers. The primary hypothesis of the present study is that early response can be pinpointed by PET reflecting both tumor burden and activity, as a surrogate for final outcome. An increasing number of studies have suggested the potential role of 18F-FDG PET in the staging and monitoring of lymphomas. The optimal timing of PET scans and the potential role of quantitative PET using SUV to assess response to chemotherapy remain to be defined. Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a homogenous group of aggressive lymphoma patients would potentially change the prognosis of the patient by allowing earlier use of alternative therapies and discontinuation of therapy that will not lead to a significant tumour response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJuly 6, 2011
July 1, 2011
5.4 years
February 3, 2006
July 2, 2011
Conditions
Keywords
Study Arms (1)
Single group study
Interventions
One extra PET scan after 1 cycle of treatment.
Eligibility Criteria
Community sample according to the area covered by the participating centers
You may qualify if:
- Age ≥ 18 years.
- Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.
- Ann Arbor stage IIB-IV.
- Written informed consent.
You may not qualify if:
- Previously treated with chemotherapy or irradiation.
- Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
- Pregnancy.
- Lactation.
- Diabetes mellitus.
- Extreme adipositas.
- Claustrophobia.
- Active inflammatory disease or infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital at Herlevlead
- Nordic Lymphoma Groupcollaborator
Study Sites (1)
Department of Hematology, Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars M Pedersen, MD
Nordic Lymphoma Group (Large Cell Group)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 6, 2006
Study Start
August 1, 2005
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
July 6, 2011
Record last verified: 2011-07