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

ABSTRACT: 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.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.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.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.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.

SUBMITTER: Pinato DJ

PROVIDER: S-EPMC3500322 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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

Pinato David J DJ Stavraka Chara C Tanner Mark M Esson Audrey A Jacobson Eric W EW Wilkins Martin R MR Libri Vincenzo V

PloS one 20121116 11

<h4>Background</h4>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.<h4>Aim</h4>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 ...[more]

PMID: 23166776

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Project description:BACKGROUND AND OBJECTIVES: The combination of cromolyn and ibuprofen is being investigated as a treatment for early Alzheimer's disease (AD). This study investigated the pharmacokinetics, safety, and tolerability of cromolyn and ibuprofen co-administration in healthy elderly adult volunteers.MethodsIn this open-labeled study, 26 subjects, aged 55-75 years, received co-administration of inhaled cromolyn (single dose 17.1 mg; double dose 34.2 mg total) and oral ibuprofen (single dose 10 mg; double dose 20 mg total). Blood sampling was performed for 6 h after co-administration in all subjects; cerebrospinal fluid (CSF) was collected in three to four subjects per cohort for 4 h following co-administration. Safety parameters, including adverse events (AEs), were monitored throughout the study.ResultsFor cromolyn, the mean (±SD) maximum observed concentration (C max) in plasma was 46.69 ± 32.97 and 96.75 ± 46.22 ng/ml after single- and double-dose inhalation, respectively [time to C max (t max) ~22 min for each; terminal elimination half-life (t ½) ~1.8 h for each]. For ibuprofen, the plasma C max was 1090.98 ± 474.64 ng/ml and 2062.96 ± 655.13 ng/ml after single- and double-dose oral administration, respectively (t max ~1.6-1.8 h; t ½ ~1.9 h for each). For cromolyn, the CSF C max was 0.24 ± 0.08 ng/ml at 3.72 ± 0.70 h after single-dose administration and 0.34 ± 0.17 ng/ml at 3.45 ± 0.95 h after double-dose administration, and for ibuprofen, the CSF C max was 3.94 ± 1.29 ng/ml at 2.55 ± 0.96 h after single-dose administration and 8.93 ± 3.29 ng/ml at 3.15 ± 1.05 h after double-dose administration. Three (12%) subjects reported mild or moderate AEs which were unlikely to be related to study drug.ConclusionsThe combination of cromolyn and ibuprofen was safe and well tolerated. The concentrations of cromolyn and ibuprofen observed in the CSF are considered sufficient to titrate the estimated daily amyloid production and the associated inflammatory response in patients with AD.

Dataset Information

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

Publications

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

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