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

July 2, 2013 updated by: R.A.J. Nievelstein, UMC Utrecht

Whole-body MR Imaging for Staging Malignant Lymphomas

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academic Medical Center Amsterdam
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3818 ES
        • Meander Medical Center Amersfoort

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
December 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
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
December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Rutger A. J. Nievelstein, MD PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80-82310-98-08012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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