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
2 other identifiers
observational
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 3, 2015
December 1, 2015
3 years
October 19, 2011
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Eligibility Criteria
Hodgkin's Lymphoma
You may qualify if:
- 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
You may not qualify if:
- Contraindications to MRI (e.g. pacemaker)
- Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
- Pregnancy or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College London Hospital (UCLH)
London, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart A Taylor, Prof
UCLH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 25, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
October 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12