lymph node cancer Malignant lymphomas
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - male or female patients - age: 8-17 years - 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
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 -Apparent signs of resistance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed