title: Clinical, ethical and financial implications of incidental imaging findings: experience from a phase I trial in healthy elderly volunteers.
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The National Institute for Health Research (NIHR)-Wellcome Trust Imperial College Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College, Hammersmith Hospital Campus, London, United Kingdom.
authors.forename: David J
authors.initials: DJ
authors.lastname: Pinato
authors.forename: Chara
authors.initials: C
authors.lastname: Stavraka
authors.forename: Mark
authors.initials: M
authors.lastname: Tanner
authors.forename: Audrey
authors.initials: A
authors.lastname: Esson
authors.forename: Eric W
authors.initials: EW
authors.lastname: Jacobson
authors.forename: Martin R
authors.initials: MR
authors.lastname: Wilkins
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Libri
mesh_terms: D000368:Aged; D017321:Clinical Trials, Phase I as Topic; D003362:Cost-Benefit Analysis; D026690:Ethics, Clinical; D005260:Female; D006801:Humans; D033162:Incidental Findings; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D015995:Prevalence