The aims of this study are to compare the diagnostic performance of whole-body MRI (including DWIBS) to FDG-PET/CT and/or CT for the initial staging, early response assessment and restaging after completion of therapy in children with Hodgkin*s…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the clinical stage according to whole-body
MRI/DWIBS findings and according to FDG-PET/CT and/or CT-findings. This
clinical stage will be determined according to the Ann Arbor classification
system for initial staging and according to the Cheson criteria for early
response assessment and restaging. The interobserver variability of the MRI
assessment will be evaluated.
Secondary outcome
The secondary outcome will be a (subjective) assessment of image quality and
presence of artefacts, for T1-weighted, T2-weighted and DWIBS MR images as well
as FDG-PET/CT and/or CT.
Furthermore, following the initial staging MRI and FDG-PET/CT examinations,
patients will be asked to complete a short questionnaire to evaluate the
perception of burden of undergoing MRI and FDG-PET/CT.
Background summary
The malignant lymphomas, Hodgkin*s lymphoma (HL) and non-Hodgkin*s lymphoma
(NHL), comprise approximately 10% of childhood cancers. The assessment of
extent of disease (staging) and response to therapy (restaging) is performed
with 18F-fluorodeoxyglucose positron emission tomography (FDG-PET scan),
computed tomography (CT) scan or integrated FDG-PET/CT. Staging and restaging
are important for choice of treatment and for determining prognosis.
Unfortunately, FDG-PET and CT are accompanied by a significant amount of
radiation exposure which may induce second cancers. New magnetic resonance
imaging (MRI) techniques offer an alternative way for staging and follow-up of
cancers. Whole-body MRI with diffusion weighted imaging (WB-MRI with DWIBS) is
a radiation-free method which allows imaging of the body with excellent soft
tissue contrast in a single examination and could be an attractive alternative
to FDG-PET and CT for the initial staging, response assessment and restaging of
malignant lymphomas in children.
Study objective
The aims of this study are to compare the diagnostic performance of whole-body
MRI (including DWIBS) to FDG-PET/CT and/or CT for the initial staging, early
response assessment and restaging after completion of therapy in children with
Hodgkin*s lymphoma.
Study design
Patients eligible for enrollment in this multicenter, prospective, diagnostic
cohort study are children aged 8-18 years, with histologically confirmed
Hodgkin lymphoma, who are treated according to the SKION / Euronet-PHL-C1
protocol in one of the participating centers. Patients will undergo WB-MRI on
top of the protocollar imaging routinely done (FDG-PET(/CT) scan and CT) at 3
time-points: at initial staging, after 2 chemotherapy cycles and at end of
treatment. We expect to enrol 75 patients in a 3 year study period. Staging and
restaging results of WB-MRI (according to the Ann Arbor and Cheson
classification, respectively) will be compared to those of FDG-PET(/CT) and CT.
All imaging modalities will be assessed by a radiologist and nuclear medicine
physician in a blinded fashion, using standardized score forms. Findings of
FDG-PET and CT together will serve as the reference standard. Clinical and
radiological follow-up after 6 months will be used to solve any disagreements
between FDG-PET, CT and WB-MRI. Furthermore, clinical and radiological 3-year
follow-up data will be obtained from hospital charts of the patients, to enable
better evaluation of the prognostic value of MRI and FDG-PET on recurrence of
disease.
Study burden and risks
The patient has to lie in the MRI-scanner fo approximately 50 minutes. This
MRI-scan is completely non-invasive and has no adverse side-effects.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- male or female patients
- age: 8-18 years
- histologically proven Hodgkin's disease
- enrolled in the EuroNet-PHL-C1 trial
- patients scheduled for a FDG-PET/CT or CT of the body for initial staging, early response assessment or restaging at end of treatment
- the participant must willingly give written informed consent prior to the start of the study and before each MRI
- Whole-body MRI has to be performed within 15 days before or after FDG-PET/CT or 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 FDG-PET/CT and before MRI could be performed
-Apparent signs of resistance
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 | NL34472.041.10 |