Whole-body MR imaging for staging malignant lymphomas in adults

Completed

Conditions: lymph node cancer
Malignant lymphomas
10025323

Registration Number: NL-OMON31806

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

- male or female patients
- age: 18 years and older
- 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

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