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Malignant LymphomaNCT00685997

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

An observational study of Malignant Lymphoma and Hodgkin's Disease, run by UMC Utrecht at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 years and older
How many people
135 participants
Where
3 sitesNetherlands
Study dates
Jun 2008to Jun 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Meander Medical Center Amersfoort

    Amersfoort, Utrecht, 3818 ES

  • Academic Medical Center Amsterdam

    Amsterdam, North Holland, 1105 AZ

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Keywords
Malignant lymphoma, Hodgkin's disease, Non-Hodgkin's lymphoma, Imaging, Whole-Body MRI, CT, Radiation
Medical subject headings
Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: December 2010

Secondary outcomes (1)

  1. 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.

    Measured: December 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685997
Sponsor's protocol ID
80-82310-98-08012
Status last verified
Jul 2013
First submitted
27 May 2008
Last updated
3 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Brennan DD, Gleeson T, Coate LE, Cronin C, Carney D, Eustace SJ. A comparison of whole-body MRI and CT for the staging of lymphoma. AJR Am J Roentgenol. 2005 Sep;185(3):711-6. doi: 10.2214/ajr.185.3.01850711.

    PubMed 16120924

  • Kellenberger CJ, Epelman M, Miller SF, Babyn PS. Fast STIR whole-body MR imaging in children. Radiographics. 2004 Sep-Oct;24(5):1317-30. doi: 10.1148/rg.245045048.

    PubMed 15371611

  • Lauenstein TC, Goehde SC, Herborn CU, Goyen M, Oberhoff C, Debatin JF, Ruehm SG, Barkhausen J. Whole-body MR imaging: evaluation of patients for metastases. Radiology. 2004 Oct;233(1):139-48. doi: 10.1148/radiol.2331030777. Epub 2004 Aug 18.

    PubMed 15317952

  • Antoch G, Vogt FM, Freudenberg LS, Nazaradeh F, Goehde SC, Barkhausen J, Dahmen G, Bockisch A, Debatin JF, Ruehm SG. Whole-body dual-modality PET/CT and whole-body MRI for tumor staging in oncology. JAMA. 2003 Dec 24;290(24):3199-206. doi: 10.1001/jama.290.24.3199.

    PubMed 14693872

  • Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

    PubMed 18046031

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Lymphoma and Hodgkin's Disease, run by UMC Utrecht at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685997, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.

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