Whole-body MRI for initial staging, early response assessment and restaging after completion of therapy in pediatric Hodgkin lymphoma.

Completed

Conditions: Hodgkin lymphoma
lymph node cancer
10025319

Registration Number: NL-OMON41368

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the clinical stage according to whole-body<br /><br>MRI/DWIBS findings and according to FDG-PET/CT and/or CT-findings. This<br /><br>clinical stage will be determined according to the Ann Arbor classification<br /><br>system for initial staging and according to the Cheson criteria for early<br /><br>response assessment and restaging. The interobserver variability of the MRI<br /><br>assessment will be evaluated. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome will be a (subjective) assessment of image quality and<br /><br>presence of artefacts, for T1-weighted, T2-weighted and DWIBS MR images as well<br /><br>as FDG-PET/CT and/or CT.<br /><br>Furthermore, following the initial staging MRI and FDG-PET/CT examinations,<br /><br>patients will be asked to complete a short questionnaire to evaluate the<br /><br>perception of burden of undergoing MRI and FDG-PET/CT.</p><br>