Clinical trial NCT01459224: MELT - MRI Evaluation of Lymphoma Treatment
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Hodgkin
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hodgkin's Lymphoma

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: The recruited patients to be followed up for 1 year
Secondary outcomes:
measure: The number of correct patient classifications into therapy responders and non-responders by MRI compared to the multi modality reference
timeFrame: The recruited patients to be followed up for 1 year
measure: Inter observer agreement for MRI between reporting radiologists (on site and off site). responders by MRI compared to the multi modality reference
timeFrame: The recruited patients to be followed up for 1 year
measure: Sensitivity, specificity of qualitative assessment of Minimum intensity projection (MIP) inverted high B value datasets
timeFrame: The recruited patients to be followed up for 1 year
measure: Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease
timeFrame: The recruited patients to be followed up for 1 year
measure: Simulated effect of MRI on clinical management via external oncologic review
timeFrame: The recruited patients to be followed up for 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital (UCLH)
Study officials:
affiliation: UCLH
name: Stuart A Taylor, Prof
role: PRINCIPAL_INVESTIGATOR
References: