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Clinical, ethical and financial implications of incidental imaging findings: experience from a Phase I trial in healthy elderly volunteers

Pinato, DJ; Stavraka, C; Tanner, M; Esson, A; Jacobson, EW; Wilkins, MR; Libri, V; (2012) Clinical, ethical and financial implications of incidental imaging findings: experience from a Phase I trial in healthy elderly volunteers. PLoS One , 7 (11) , Article e49814. 10.1371/journal.pone.0049814. Green open access

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Abstract

Background The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care. Aim To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the follow-up pathway with consequent cost implications and impact on trial outcomes. Methods A total of 29 elderly healthy volunteers (mean age 67, range 61–77, 59% female) were eligible at screening and underwent MRI for assessment of visceral and subcutaneous fat. Results IF were detected in 19 subjects (66%). Suspected IF of high and low clinical significance were found in 14% and 52% of participants, respectively. Follow up of IF was conducted in 18 individuals, confirming abnormalities in 13 subjects, 3 of whom were recommended for deferred clinical re-evaluation. The remaining 5 subjects had false positive IF based on second line imaging tests. Costs of follow-up medical care were considerable. Conclusion MRI abnormalities are common in elderly individuals, as a result of age and non-diagnostic quality of research scans. In the presence of IF in the context of clinical trials, immediate referrals and follow up assessments may be required to rule out suspected pathology prior to exposing trial participants to investigational medicine products (IMP). Unanticipated costs, ethical implication and the possible impact of IF on trial outcomes need to be taken into account when designing and conducting trials with an IMP.

Type: Article
Title: Clinical, ethical and financial implications of incidental imaging findings: experience from a Phase I trial in healthy elderly volunteers
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1371/journal.pone.0049814
Publisher version: http://dx.doi.org/10.1371/journal.pone.0049814
Language: English
Additional information: © 2012 Pinato et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. PMCID: PMC3500322
Keywords: Aged, Clinical Trials, Phase I as Topic, Cost-Benefit Analysis, Ethics, Clinical, Female, Humans, Incidental Findings, Magnetic Resonance Imaging, Male, Middle Aged, Outcome Assessment (Health Care), Prevalence
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > IoN Central Administration
URI: https://discovery.ucl.ac.uk/id/eprint/1403212
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