Protocol for PARA-PET: a trial of [18F]fluorocholine PET/CT versus conventional imaging for primary hyperparathyroidism with randomised order of blinded imaging assessment

Abstract

Abstract Introduction Primary hyperparathyroidism is a common endocrine condition due to inappropriate parathyroid hormone production from one or more parathyroid glands. Surgery is curative. Imaging performed preoperatively aims to accurately localise the responsible gland(s) to facilitate minimally invasive surgery. Current imaging techniques with neck ultrasound (US), sestamibi single-photon emission tomography (SPECT)/CT and four-dimensional CT (4DCT) are imperfect. [18F]Fluorocholine (FCH) PET/CT is a novel modality offering several advantages, including improved accuracy, lower radiation exposure and shorter imaging time. This protocol describes PARA-PET, a non-inferiority trial designed to compare FCH PET/CT to conventional imaging for primary hyperparathyroidism. Methods and analysis 134 patients with primary hyperparathyroidism referred for surgery will receive FCH PET/CT in addition to conventional imaging (sestamibi SPECT/CT and 4DCT), as well as neck US for operative planning. All imaging techniques will be reviewed at a monthly multidisciplinary meeting, attended by representatives from Endocrinology, Endocrine Surgery, Nuclear Medicine and Radiology. Participants will be randomised 1:1 to the order in which the diagnostic strategy will be reviewed first, with interpretation blinded to alternative imaging arm results. The intended surgical approach will be prospectively documented. Clinical outcomes will be followed up at 1 and 6 months post-surgery. Additional analyses will include accuracy, patient satisfaction, cost effectiveness and environmental impact of each imaging technique. Ethics and dissemination The study has received ethical approval from the Metro North Health Research Ethics Committee (Project ID: 113012; HREC/2025/MNH/113012). Participants will be sent a letter summarising the study results and inviting them to contact the research team with any questions. The trial will be published in an international peer-reviewed journal. Abstracts will also be submitted to relevant national and international endocrine and nuclear medicine scientific meetings. Trial registration ANZCTR ACTRN12625000509460.