MELT - MRI Evaluation of Lymphoma Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01459224
First received: October 19, 2011
Last updated: October 21, 2011
Last verified: July 2011
  Purpose

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
Lymphoma, Hodgkin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Simulated effect of MRI on clinical management via external oncologic review [ Time Frame: The recruited patients to be followed up for 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hodgkin's Lymphoma

Criteria

Inclusion Criteria:

  • Aged 6 to 18 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459224

Contacts
Contact: Ka Man Condne, BSc, MSc 02076799860 melt@ctc.ucl.ac.uk
Contact: Haematology Trials Group CRUK & UCL Cancer Trials Centre 02076799860 bnli@ctc.ucl.ac.uk

Locations
United Kingdom
University College London Hospital (UCLH) Recruiting
London, United Kingdom
Principal Investigator: Stuart A Taylor, Prof         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Stuart A Taylor, Prof UCLH
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01459224     History of Changes
Other Study ID Numbers: UCL10/0271, CRUK ASC 12707
Study First Received: October 19, 2011
Last Updated: October 21, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014