Use of 18F-fluorodeoxyglucose positron emission tomography to standardize clinical trial recruitment in Takayasu’s arteritis

Abstract

Objectives To assess whether data from FDG-PET should be incorporated into eligibility criteria for clinical trials in Takayasu’s arteritis (TAK). Methods The study was conducted in two parts. Part One was an international online survey among physicians with experience managing TAK to determine, using clinical vignettes, whether FDG-PET data influences decisions about enrolment in trials. Part Two used patient data from an observational cohort study in TAK to assess agreement regarding decisions about enrolment into trials, based on clinical assessment with and without incorporation of FDG-PET data. Results In Part One, 68 physicians responded to the survey. Most physicians had used FDG-PET to diagnose TAK (82%) or monitor disease activity (66%). In vignettes representing active clinical disease, FDG-PET findings increased physician confidence in disease assessment and reduced outlier assessments. The greatest variability in decisions regarding enrolment into trials was observed in vignettes representing constitutional symptoms alone and elevated acute phase reactants. In these cases, FDG-PET findings influenced decisions about enrolment and improved physician confidence. In multivariable models, FDG-PET findings were 1.29x more strongly associated with enrolment decisions compared with levels of acute phase reactants. In Part Two, incorporation of FDG-PET data significantly improved agreement about enrolment decisions between raters, (IRR = 0.68 [95%CI (0.67–0.69)] to IRR = 0.88 [95%CI 0.87–0.89]; p< 0.01). Conclusions Incorporation of FDG-PET data into assessment of TAK influences decisions about enrolment of patients into trials, improves physician confidence about clinical assessment, and could help reduce variability in study populations. Future trials in TAK should consider incorporating FDG-PET data into eligibility criteria.

Impact of Geographic Location on Diagnosis and Initial Management of Takayasu Arteritis: A Tale of Two Cohorts from Italy and India

“…It must be noted that PET-CT often identifies a proportion of active vascular disease in TAK where the CRP is normal [ 8 , 47 ]. A recent survey of international experts in TAK suggested the feasibility of the use of PET-CT as a screening modality for active disease before the recruitment of patients in clinical trials of TAK [ 48 ]. The increasing use of PET for LVV disease activity assessment in lesser economically developed settings such as India shall hopefully enable the wider inclusivity of patients in future clinical trials of TAK.…”

Outcome Measures and Biomarkers for Disease Assessment in Takayasu Arteritis

“…None of the high-quality trials have met their primary endpoint. A recent survey of international experts in TAK suggested the feasibility of using PET-CT to homogenize clinical trial recruitment in TAK [ 80 ].…”

Survey-based observational research: Quality, relevance and optimal use in the post-COVID-19 era

“…As an example, a recent survey attempted to understand the perspectives of international experts in Takayasu arteritis (a rare disease) on the use of the imaging modality of positron emission tomography to homogenise recruitment of patients into clinical trials of Takayasu arteritis. 5…”

“…8 The survey sample is well defined when experts are individually invited to participate in a survey. 5 In any case, the sampling strategy along with its advantages or disadvantages should be clearly mentioned in the survey report.…”

“…As an example, a recent survey attempted to understand the perspectives of international experts in Takayasu arteritis (a rare disease) on the use of the imaging modality of positron emission tomography to homogenise recruitment of patients into clinical trials of Takayasu arteritis. 5 Surveys could also be useful to gather data to enable the development of policies related to education or public health. As an example, a recent survey attempted to understand the perspectives of physicians from India regarding their perceived adequacy of rheumatology training during undergraduate medical education or postgraduate training.…”