The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a malignant lymphoma.
ID
Source
Brief title
Condition
- Lymphomas NEC
- Lymphomas NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The challenge of this study will be to show non-inferiority of WB-MRI compared
to CT in staging malignant lymphoma (according to the Ann Arbor
classification). Testing of this hypothesis will be one-sided and performed
using recently
proposed techniques by Lui et al. [Lui KJ, et al. Testing non-inferiority (and
equivalence) between two diagnostic procedures in paired-sample ordinal data.
Stat Med 2004;23:545-59].
Secondary outcome
Image quality DWIBS-scan at different magnetic field strengths:
Average apparent contrast-to-noise ratio's with corresponding standard
deviations of DWIBS0-images obtained in 20 of 110 patients at 1.0 T, 1.5 T, and
3.0 T will be compared
Radiation-related risk assessment (CT-scan):
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 [Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR
VII Phase 2, Committee to Assess Health Risks from Exposure to Low Levels of
Ionizing Radiation, National Research Council, 2006, ISBN: 030909156X].
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.
Background summary
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. Moreover, the intravenous application of a
contrast agent necessary for CT can cause allergic reactions and may cause
contrastnephropathy. 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), including diffusion-weighted sequences
(DWIBS), is a radiation-free method which allows imaging of the body with
excellent soft tissue contrast in a single examination, without the application
of a contrast agent.
Study objective
The aim of this study is to examine if WB-MRI can replace CT in staging of
patients with a malignant lymphoma.
Study design
This will be a unicenter, prospective, diagnostic cohort study (timeschedule:
36 months). 110 eligible patients will undergo WB-MRI on top of the protocollar
imaging routinely done.
For optimalization of the DWIBS-sequence, 20 of 110 included patients will also
undergo a DWIBS-scan (i.e. only a DWIBS-scan, no conventional whole-body MRI)
on another MRI-scanner, respectively 10 at 1.0 T and 10 at 3.0 T.
Study burden and risks
The patient has to lie in the MRI-scanner for approximately 45 minuten. 20 of
110 included patients will undergo an extra MRI-scan in another MRI-scanner,
which will take approximately 20-25 minutes. All MRI-scans are completely
non-invasive and without any adverse side-effects.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- male or female patients
- age: 18 years and older
- histologically proven Hodgkin's disease or non-Hodgkin's lymphoma
- patients scheduled for a CT of the body for initial staging and follow-up
- the participant must willingly give written informed consent prior to the start of the study
- Whole-body MRI has to be performed within 10 days before or after CT, and before therapy has been started.
Exclusion criteria
- patients with a general contraindication for MRI (including cardiovascular pacemakers, claustrofobia)
- patients who have had a previous malignancy
- patients who are pregnant or nursing
- patients in whom therapy has already started after CT and before MRI could be performed
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16857.041.07 |