Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Whole-body MR Imaging for Staging Malignant Lymphomas
Background:
The malignant lymphomas, Hodgkin´s disease (HD) and non-Hodgkin´s lymphoma (NHL), comprise
approximately 5-6% of all malignancies in adults and account for 10% of childhood cancers.
Once the diagnosis has been established histologically, extent of disease (staging) and
response to therapy will be assessed by means of a computed tomography (CT) scan of the
body. The staging at presentation is important for determining prognosis and choice of
treatment. Unfortunately, CT is accompanied by a significant amount of radiation exposure
which may induce second cancers. This is especially important in childhood, because rapidly
dividing cells are more sensitive to radiation induced effects and children will have more
years ahead in which cancerous changes might occur. New magnetic resonance imaging (MRI)
techniques offer an alternative way for staging and follow-up of cancers, including the
malignant lymphomas. Whole-body MRI (WB-MRI) is a radiation-free method which allows imaging
of the body with excellent soft tissue contrast in a single examination.
Purpose:
The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a
malignant lymphoma.
Design:
This will be a multicenter, prospective, diagnostic cohort study (timeschedule: 36 months).
135 eligible patients will undergo WB-MRI on top of the protocolar imaging routinely done.
Study population:
Patients aged 8 years and older with a histological diagnosis of HD or NHL.
Statistical analysis:
The challenge of this study will be to show non-inferiority of WB-MRI compared to CT in
staging malignant lymphoma. Testing of this hypothesis will be one-sided and performed using
recently proposed techniques by Lui et al.
Radiation-related risk assessment:
A risk model will be used, based on the BEIR VII report, for modelling the late-term
mortality from radiation induced tumors after exposure to ionizing radiation.
Economic evaluation:
Actual costs (from a societal perspective) will be determined for the two diagnostic tests.
In case of clinical equivalence and similar costs or cost savings associated with MRI the
latter can be considered dominant, obviating further economic evaluation. Otherwise, through
modelling of expected long term health impact and associated outcomes such as quality of
life and costs the incremental cost effectiveness will be evaluated.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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