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Completed

NCT Number: NCT01459224

MELT - MRI Evaluation of Lymphoma Treatment

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.

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Key information

Conditions

Lymphoma, Hodgkin Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London Hospital (UCLH)

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: The recruited patients to be followed up for 1 year

Secondary outcomes

  1. The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference

    Time frame: 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

    Time frame: 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

    Time frame: The recruited patients to be followed up for 1 year

  4. Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease

    Time frame: The recruited patients to be followed up for 1 year

  5. Simulated effect of MRI on clinical management via external oncologic review

    Time frame: The recruited patients to be followed up for 1 year

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: MELT

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 25, 2011
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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