Incidental findings in healthy control research subjects using whole-body MRI

doi:10.1016/j.ejrad.2008.08.006

European Journal of Radiology

Volume 72, Issue 3, December 2009, Pages 529-533

https://doi.org/10.1016/j.ejrad.2008.08.006 Get rights and content

Abstract

Aim

Magnetic resonance imaging (MRI) is a powerful clinical tool used increasingly in the research setting. We aimed to assess the prevalence of incidental findings in a sequential cohort of healthy volunteers undergoing whole-body MRI as part of a normal control database for imaging research studies.

Materials and methods

148 healthy volunteers (median age 36 years, range 21–69 years; 63.5% males, 36.5% females) were enrolled into a prospective observational study at a single hospital-based MRI research unit in London, UK. Individuals with a clinical illness, treated or under investigation were excluded from the study.

Results

43 (29.1%) scans were abnormal with a total of 49 abnormalities detected. Of these, 20 abnormalities in 19 patients (12.8%) were of clinical significance. The prevalence of incidental findings increased significantly with both increasing age and body mass index (BMI). Obese subjects had a fivefold greater risk of having an incidental abnormality on MRI (OR 5.4, CI 2.1–14.0).

Conclusions

This study showed that more than one quarter of healthy volunteers have MR-demonstrable abnormalities. There was an increased risk of such findings in obese patients. This has ethical and financial implications for future imaging research, particularly with respect to informed consent and follow-up of those with abnormalities detected during the course of imaging studies.

Introduction

Modern medical imaging provides some of the most sensitive diagnostic tools for the detection of human pathology and these techniques have profoundly changed the way medicine is practiced, owing to their accuracy and relative lack of invasiveness. Given these advantages, medical imaging has been increasingly used in the research setting. Magnetic resonance imaging (MRI) provides superior tissue contrast without exposure to ionizing radiation and is becoming ever more popular in research studies, in parallel with its greater prevalence in standard clinical usage, although contraindications to high magnetic field strength exposure, the duration of scanning and limited evaluation of lung parenchyma may limit its applicability in some settings. The potential role of MRI as a screening tool has also recently been proposed for the detection of several diseases, such as cerebral aneurysms [1], bone metastases [2], pulmonary disease [3], cardiovascular disease [4], [5], and colonic polyps [6]. Developments in whole-body imaging protocols including diffusion-weighted imaging and positron emission tomography are moving towards microscopic and metabolic assessments [7], [8], [9]. In both clinical and research settings, there is regular detection of incidental abnormalities, which are defined as unexpectedly discovered findings in healthy subjects, or those that are unrelated to the purpose of the study [10], [11]. Studies have demonstrated the prevalence of incidental finding in a number of clinical settings including MR imaging of the brain [12], [13], cardiac MR [14], dark lumen MR colonography [15], and contrast-enhanced MR imaging of the breast [16]. The use of whole-body imaging in research raises ethical issues with regards to the detection of such unexpected abnormalities, the provision of informed consent, the recruitment of healthy controls into imaging research studies and the follow-up of subjects in whom abnormalities have been found.

In this study we report the rate of incidental findings on whole-body MRI in a cohort of consecutively recruited healthy volunteers in the research setting.

Section snippets

Sampled population

From July 2006 to July 2007 148 research subjects were enrolled to take part in a study on the distribution of body fat using whole-body MRI scans in a hospital-based imaging research unit, having responded to posters advertising the study. The study was conducted in accordance with the ethical standards of the World Medical Association (Declaration of Helsinki) and the subjects did not receive payment for participation in the study. Informed consent was obtained from all subjects by the

Results

148 healthy volunteers, consecutively recruited for whole-body MR body-fat imaging, were included in the analysis. The study population comprised 94 (63.5%) male and 54 (36.5%) female. The population cohort had a median age of 36 years (range 21–69 years). The median BMI was 25.5 (range 15.4–47.5).

43 (29.1%) subjects had at least one abnormality on whole-body MR scanning (Fig. 1). 37 individuals had a single abnormality and 6 individuals had two abnormalities each; a total of 49 abnormalities.

Discussion

In this cohort of 148 consecutively recruited healthy volunteers who underwent whole-body MR imaging as part of a normal control database for MR research studies, the prevalence of unexpected abnormalities was 29.1%, while 3.4% of subjects were found to have an abnormality of high clinical significance and a total of 12.8% had abnormalities of high or moderate clinical significance. The prevalence of abnormalities was higher in older subjects and in those with a higher BMI. Although BMI is

Conclusions

In this study of a cohort of healthy volunteers undergoing whole-body MRI as part of a research protocol, more than a quarter of subjects were found to have incidental abnormalities. The risk of having an unexpected abnormality was markedly increased in obese subjects. This has ethical implications for the conduct of clinical research studies. A quantitative assessment of the financial effects of whole body imaging in a research setting should be explored. In addition, a formal cost-benefit

Acknowledgements

Funding for research studies has been provided by the British Medical Research Council, The United Kingdom National Health Service Research and Development Fund and Philips Medical Systems (Best, Netherlands). SHXM is supported by a grant from the Société des Radiologistes de l’Hôpital St-François d’Assise, Québec, Canada; JFLC by a Centenary Fellowship from the Trustees of the Hammersmith Hospital in London; SRM by a Fellowship from Novo Nordisk UK Research Foundation. All authors are grateful

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However, the prevalence of reported IF in our study is consistent with the frequencies of potentially serious IF previously published in other whole-body MR cohort studies. For example, IF frequencies of 12.8 % in healthy control research subjects [12] and 17.9 % [7] up to 31.5 % in the general adult population have previously been reported [13]. We also confirm prior research by demonstrating no significant differences in IF between participants with diabetes, prediabetes and normal glucose tolerance, while there was a significant, stepwise trend of having diabetes-related IF between participants with normal glucose tolerance, prediabetes and diabetes.
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¹: These authors have contributed equally to this work.

²: Department of Gastroenterology and Hepatology, Division of Medicine, Imperial College London, Hammersmith Hospital, Du Cane Road, London W12 0NN, United Kingdom, Tel +44 20 8383 5856; fax +44 20 749 8068.

³: Department of Radiology, Charing Cross Hospital, Fulham Palace Road, Hammersmith, London W6 9NT, United Kingdom. Tel.: +44 20 8846 1234; fax: +44 20 8383 3038.

⁴: Tel.: +44 20 7594 3421; fax: +44 20 7594 1489.

⁵: Robert Steiner MRI Unit, Imaging Sciences Department, MRC Clinical Sciences Centre, Imperial College London, Hammersmith Hospital, Du Cane Road, London W12 0NN, United Kingdom.

⁶: Department of Endocrinology & Metabolic Medicine, Imperial College London (St Mary’s Campus), Praed Street, London W2 1NY, United Kingdom. Tel.: +44 207 886 6120; fax: +44 207 886 1790.

View full text

Incidental findings in healthy control research subjects using whole-body MRI

Abstract

Aim

Materials and methods

Results

Conclusions

Introduction

Section snippets

Sampled population

Results

Discussion

Conclusions

Acknowledgements

Surg Neurol

Clin Radiol

Eur J Radiol

J Am Coll Radiol

J Am Acad Child Adolesc Psychiatry

Whole-body magnetic resonance imaging: techniques, clinical indications, and future applications

Semin Musculoskelet Radiol

HASTE MRI versus chest radiography in the detection of pulmonary nodules: comparison with MDCT

Am J Roentgenol

Whole body MR angiography screening

Int J Cardiovasc Imaging

Cardiovascular screening with parallel imaging techniques and a whole-body MR imager

Radiology

Whole-body imaging of the musculoskeletal system: the value of MR imaging

Skeletal Radiol

Evaluation of whole-body cancer screening using (18)F-2-deoxy-2-fluoro-d-glucose positron emission tomography: a preliminary report

Ann Nucl Med

Ethics. Incidental findings in brain imaging research

Science

Subjects’ expectations in neuroimaging research

J Magn Reson Imaging

Clinically serious abnormalities found incidentally at MR imaging of the brain: data from the Cardiovascular Health Study

Radiology

Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic volunteers

JAMA