Whole-body Magnetic Resonance Imaging (MRI) for Staging Malignant Lymphomas

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
R.A.J. Nievelstein, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00685997
First received: May 27, 2008
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

Background:

The malignant lymphomas, Hodgkin´s disease (HD) and non-Hodgkin´s lymphoma (NHL), comprise approximately 5-6% of all malignancies in adults and account for 10% of childhood cancers. Once the diagnosis has been established histologically, extent of disease (staging) and response to therapy will be assessed by means of a computed tomography (CT) scan of the body. The staging at presentation is important for determining prognosis and choice of treatment. Unfortunately, CT is accompanied by a significant amount of radiation exposure which may induce second cancers. This is especially important in childhood, because rapidly dividing cells are more sensitive to radiation induced effects and children will have more years ahead in which cancerous changes might occur. New magnetic resonance imaging (MRI) techniques offer an alternative way for staging and follow-up of cancers, including the malignant lymphomas. Whole-body MRI (WB-MRI) is a radiation-free method which allows imaging of the body with excellent soft tissue contrast in a single examination.

Purpose:

The aim of this study is to examine if WB-MRI can replace CT in staging of patients with a malignant lymphoma.

Design:

This will be a multicenter, prospective, diagnostic cohort study (timeschedule: 36 months). 135 eligible patients will undergo WB-MRI on top of the protocolar imaging routinely done.

Study population:

Patients aged 8 years and older with a histological diagnosis of HD or NHL.

Statistical analysis:

The challenge of this study will be to show non-inferiority of WB-MRI compared to CT in staging malignant lymphoma. Testing of this hypothesis will be one-sided and performed using recently proposed techniques by Lui et al.

Radiation-related risk assessment:

A risk model will be used, based on the BEIR VII report, for modelling the late-term mortality from radiation induced tumors after exposure to ionizing radiation.

Economic evaluation:

Actual costs (from a societal perspective) will be determined for the two diagnostic tests. In case of clinical equivalence and similar costs or cost savings associated with MRI the latter can be considered dominant, obviating further economic evaluation. Otherwise, through modelling of expected long term health impact and associated outcomes such as quality of life and costs the incremental cost effectiveness will be evaluated.


Condition
Malignant Lymphoma
Hodgkin's Disease
Non-Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Whole-body MR Imaging for Staging Malignant Lymphomas

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • The primary outcome will be the clinical stage according to WB-MRI findings and according to CT-findings. This clinical stage will be determined according to the Ann Arbor classification system. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome will be a (subjective) assessment of image quality and presence of artefacts, for both T1-weighted and T2-weighted MR images as well as CT. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: June 2008
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients, aged 8 years and older, with newly diagnosed Hodgkin's disease or non-Hodgkin's lymphoma, who will undergo computed tomography (CT) for staging

Criteria

Inclusion Criteria:

  • male or female patients
  • age: 8 years and older
  • histologically proven Hodgkin's disease or non-Hodgkin's lymphoma
  • patients scheduled for a CT of the body for initial staging
  • participant's parents (participant < 18 years) or the participant (participant >18 years) must willingly give written informed consent prior to the start of the study
  • whole-body MRI has to be performed within 10 days before or after CT, and before therapy has been started.

Exclusion Criteria:

  • patients with a general contraindication for MRI (including cardiovascular pacemakers, claustrophobia)
  • patients who have had a previous malignancy
  • patients who are pregnant or nursing
  • patients in whom therapy has already started after CT and before MRI could be performed
  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: NCT00685997

Locations
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Meander Medical Center Amersfoort
Amersfoort, Utrecht, Netherlands, 3818 ES
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rutger A. J. Nievelstein, MD PhD UMC Utrecht
  More Information

Publications:
Responsible Party: R.A.J. Nievelstein, M.D., Ph.D., UMC Utrecht
ClinicalTrials.gov Identifier: NCT00685997     History of Changes
Other Study ID Numbers: 80-82310-98-08012
Study First Received: May 27, 2008
Last Updated: July 2, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Malignant lymphoma
Hodgkin's disease
Non-Hodgkin's lymphoma
Imaging
Whole-Body MRI
CT
Radiation

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

ClinicalTrials.gov processed this record on October 19, 2014