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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41368
Enrollment
60
Registered
2011-05-20
Start date
2012-04-18
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin lymphoma lymph node cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)