Whole-body MR imaging for staging malignant lymphomas in childre

Completed

Conditions: lymph node cancer
Malignant lymphomas
10025323

Registration Number: NL-OMON31205

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The challenge of this study will be to show non-inferiority of WB-MRI compared<br /><br>to CT in staging malignant lymphoma (according to the Ann Arbor<br /><br>classification). Testing of this hypothesis will be one-sided and performed<br /><br>using recently<br /><br>proposed techniques by Lui et al. [Lui KJ, et al. Testing non-inferiority (and<br /><br>equivalence) between two diagnostic procedures in paired-sample ordinal data.<br /><br>Stat Med 2004;23:545-59].</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Radiation-related risk assessment (CT-scan):<br /><br>A risk model will be used, based on the BEIR VII report, for modelling the<br /><br>late-term mortality from radiation induced tumors after exposure to ionizing<br /><br>radiation [Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR<br /><br>VII Phase 2, Committee to Assess Health Risks from Exposure to Low Levels of<br /><br>Ionizing Radiation, National Research Council, 2006, ISBN: 030909156X].<br /><br><br /><br>Economic evaluation:<br /><br>Actual costs (from a societal perspective) will be determined for the two<br /><br>diagnostic tests. In case of clinical equivalence and similar costs or cost<br /><br>savings associated with MRI the latter can be considered dominant, obviating<br /><br>further economic evaluation. Otherwise, through modelling of expected long term<br /><br>health impact and associated outcomes such as quality of life and costs the<br /><br>incremental cost effectiveness will be evaluated.</p><br>