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The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.

The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01865058
Enrollment
50
Registered
2013-05-30
Start date
2011-06-30
Completion date
2014-08-31
Last updated
2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

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.

Interventions

None listed

Sponsors

University of Southern Denmark
CollaboratorOTHER
Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression free survival2 years

Secondary

MeasureTime frame
Overall survival2 years, 3 years

Other

MeasureTime frameDescription
Treatment response (CR, PR, PD)Up to 24 weeksThe time frame is from baseline PET scanning to completions of therapy.

Countries

Denmark

Contacts

Primary ContactKaren Juul Mylam, MD
karen.mylam@rsyd.dk0045 6541 1637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026