Protocol for PARA-PET: a trial of [ ¹⁸ F]fluorocholine PET/CT versus conventional imaging for primary hyperparathyroidism with randomised order of blinded imaging assessment
10 affiliations
- 1Endocrinology and Diabetes, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
- 2Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia
- 3Endocrine Surgery, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
- 4QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia
- 5Faculty of Medicine, University of Melbourne, Melbourne, Victoria, Australia
- 6Endocrinology and Diabetes, Austin Health, Melbourne, Victoria, Australia
- 7Medical Imaging, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
- 8Nuclear Medicine and PET Services, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
- 9Statistics, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia
- 10Cancer Council Queensland, Brisbane, Queensland, Australia
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.
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BibTeX
@article{wootton2026protocol,
title = {{Protocol for PARA-PET: a trial of [ ¹⁸ F]fluorocholine PET/CT versus conventional imaging for primary hyperparathyroidism with randomised order of blinded imaging assessment}},
author = {Elizabeth Wootton and Clement Wong and Peter Donovan and Donald S A Mcleod and M Grossmann and Samuel Kyle and Louise Campbell and Anita Pelecanos and Louisa G Collins and Roslyn Francis and David A Pattison},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-122455},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122455},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Protocol for PARA-PET: a trial of [ ¹⁸ F]fluorocholine PET/CT versus conventional imaging for primary hyperparathyroidism with randomised order of blinded imaging assessment
AU - Elizabeth Wootton
AU - Clement Wong
AU - Peter Donovan
AU - Donald S A Mcleod
AU - M Grossmann
AU - Samuel Kyle
AU - Louise Campbell
AU - Anita Pelecanos
AU - Louisa G Collins
AU - Roslyn Francis
AU - David A Pattison
PY - 2026
DA - 2026/10/29
JO - BMJ Open
DO - 10.1136/bmjopen-2026-122455
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122455
AB - 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.
SN - 2044-6055
SN - 2044-6055
ER -