MELT - MRI Evaluation of Lymphoma Treatment (MELT)

Whole Body Functional and Anatomical MRI: Accuracy in Staging and Treatment Response Monitoring in Adolescent Hodgkin's Lymphoma Compared to Conventional Multimodality Imaging

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Hodgkin

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • University College London Hospital (UCLH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hodgkin's Lymphoma

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease	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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Stuart A Taylor, Prof, UCLH

Publications and helpful links

Helpful Links

• Coordinating Centre Website

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: UCL10/0271; CRUK ASC 12707 (Other Grant/Funding Number: Cancer Research UK)