MELT - MRI Evaluation of Lymphoma Treatment

Lymphoma, Hodgkin Clinical Trial

— MELT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459224
• Other study ID #: UCL10/0271
• Secondary ID: CRUK ASC 12707
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: December 1, 2015
• Start date: September 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 20 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin

Locations

Country	Name	City	State
United Kingdom	University College London Hospital (UCLH)	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Utility of apparent diffusion coefficient (ADC) histogram analysis for identifying responsive nodal disease		The recruited patients to be followed up for 1 year	No
Secondary	Simulated effect of MRI on clinical management via external oncologic review		The recruited patients to be followed up for 1 year	No

External Links

•   Coordinating Centre Website