MELT - MRI Evaluation of Lymphoma Treatment

Completed

• Conditions: Lymphoma, Hodgkin

• Registration Number: NCT01459224
• Lead Sponsor: University College, London

Brief Summary

Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an extended MRI scan.

Detailed Description

The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's lymphoma undergoing disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-25
• Primary Completion: 2014-09
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Aged 5 to 20 years (inclusive) with participant and parent/guardian informed consent
• Histologically confirmed first presentation of Hodgkin's Lymphoma
• Either entered into the Euronet PHL-C1 trial or LP1 trials OR not formally entered into the Euronet trials but treated on the chemotherapy regimens of the Euronet trials for classical and lymphocyte predominant Hodgkin Lymphoma

Exclusion Criteria

• Contraindications to MRI (e.g. pacemaker)
• Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
• Pregnancy or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The per site sensitivity and specificity of MRI for both nodal and extranodal sites and concordance in final disease stage with the multi-modality reference standard	The recruited patients to be followed up for 1 year

Secondary Outcome Measures

Name	Time	Method
Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease	The recruited patients to be followed up for 1 year
The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference	The recruited patients to be followed up for 1 year
Inter observer agreement for MRI between reporting radiologists (on site and off site). responders by MRI compared to the multi modality reference	The recruited patients to be followed up for 1 year
Sensitivity, specificity of qualitative assessment of Minimum intensity projection (MIP) inverted high B value datasets	The recruited patients to be followed up for 1 year
Simulated effect of MRI on clinical management via external oncologic review	The recruited patients to be followed up for 1 year

Trial Locations

Locations (1)

University College London Hospital (UCLH); 🇬🇧 London, United Kingdom