Clinical trial NCT00685997: Whole-body Magnetic Resonance Imaging (MRI) for Staging Malignant Lymphomas
Official title: Whole-body MR Imaging for Staging Malignant Lymphomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Lymphoma
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Keywords: Malignant lymphoma
Hodgkin's disease
Non-Hodgkin's lymphoma
Imaging
Whole-Body MRI
CT
Radiation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2008-05-29
Enrollment: 135
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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. 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.


Eligibility 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

Primary outcomes:
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.
timeFrame: December 2010
Secondary outcomes:
measure: 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.
timeFrame: December 2010
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medical Center Amersfoort
state: Utrecht
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Rutger A. J. Nievelstein, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.