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MELT - MRI Evaluation of Lymphoma Treatment

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT01459224
Collaborator
(none)
58
Enrollment
1
Location
49
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    58 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Whole Body Functional and Anatomical MRI: Accuracy in Staging and Treatment Response Monitoring in Adolescent Hodgkin's Lymphoma Compared to Conventional Multimodality Imaging
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Oct 1, 2015

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease [The recruited patients to be followed up for 1 year]

    5. Simulated effect of MRI on clinical management via external oncologic review [The recruited patients to be followed up for 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University College London Hospital (UCLH) London United Kingdom

    Sponsors and Collaborators

    • University College, London

    Investigators

    • Principal Investigator: Stuart A Taylor, Prof, UCLH

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT01459224
    Other Study ID Numbers:
    • UCL10/0271
    • CRUK ASC 12707
    First Posted:
    Oct 25, 2011
    Last Update Posted:
    Dec 3, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease

    Study Results

    No Results Posted as of Dec 3, 2015