Hodgkin lymphoma lymph node cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands