ECE2024 Rapid Communications Rapid Communications 10: Calcium and Bone | Part II (5 abstracts)
First-line F18-choline PET/CT Versus Tc99m-sestaMIBI SPECT/CT in the surgical management of primary hyperparathyroidism: a diagnostic randomized phase III trial
Elske Quak 1 , Audrey Lasne-Cardon 2 , Marie-Béatrice Cavarec 3 , Barbara Lireux 1 , Vianney Bastit 2 , Nathalie Roudaut 4 , Pierre-Yves Salaun 3 , Nathalie Keromnes 3 , Gael Potard 5 , Patricia Vaduva 6 , Annabelle Esvant 6 , Franck Jegoux 7 , Olivier De Crouy-Chanel 7 , Anne Devillers 8 , Clémence Guery 8 , François Christy 9 , Jean-Michel Grellard 9 , Stéphane Bardet 1 & Bénédicte Clarisse 9
1François Baclesse Cancer Centre, Nuclear Medicine and Thyroid Unit, Caen, France; 2François Baclesse Cancer Centre, Head and Neck Surgery, Caen, France; 3University Hospital of Brest, Nuclear Medicine, Brest, France; 4University Hospital of Brest, Endocrinology, Brest, France; 5University Hospital of Brest, Head and Neck Surgery, Brest, France; 6Rennes University Medical Center, Endocrinology, Rennes, France; 7Rennes University Medical Center, ENT, Rennes, France; 8Emgene Marquis Cancer Institute, Nuclear Medicine, Rennes, France; 9François Baclesse Cancer Centre, Clinical Research, Caen, France
Introduction: Whether F18-choline PET/CT (FCH PET/CT) should replace Tc99m-sestaMIBI SPECT/CT (MIBI SPECT/CT) as a first-line imaging technique for preoperative localisation of parathyroid adenomas in primary hyperparathyroidism (pHPT) is unclear.
Methods: We conducted a multicentre randomized open diagnostic intervention phase III trial in adults with primary hyperparathyroidism and indication for surgical treatment. Patients were assigned in a 1:1 ratio to receive first-line FCH PET/CT (FCH1) or MIBI SPECT/CT (MIBI1). In case of negative or inconclusive first-line imaging, patients received second-line FCH PET/CT (FCH2) after MIBI1 or MIBI SPECT/CT (MIBI2) after FCH1. The main aim of the trial was to compare the proportions of patients in whom the first-line imaging method resulted in successful mini-invasive parathyroidectomy (MIP) and normalisation of serum calcium levels at 1 month. We hypothesized a 30% superiority of FCH1 over MIBI1 for sample size determination (Quak et al, BMC Endocr Disord. 2021, PMID: 33413316).
Results: Overall, 57 patients received FCH1 (n=29) or MIBI1 (n=28). Baseline patient characteristics were similar between groups. Normocalcemia at 1 month after positive first-line imaging guided MIP was observed for 23 (85%) patients in the FCH1 group and 14 (56%) patients in the MIBI1 group (P=0.022). Diagnostic performances were superior for FCH1 than for MIBI1: sensitivity was 82% and 63%, and diagnostic accuracy was 79% and 64%, for FCH1 and MIBI1, respectively. Follow-up at 6 months with biochemical measures was available for 43 patients, confirming normocalcemia for all patients with normocalcemia at 1 month post-surgery. Ten patients received FCH2 and 6 patients received MIBI2. FCH2 was positive in 8/10 patients, leading to 7/9 MIP and 2/9 bilateral cervical explorations (surgery recused in 1 patient), and normocalcemia in 9/9 patients. MIBI2 was positive in 2/6 patients, leading to 1 MIP and 1 VATS; normocalcemia was obtained in all 6 patients. No adverse events related to imaging and 4 adverse events related to surgery were reported.
Conclusions: First-line FCH PET/CT is a suitable and safe replacement for MIBI SPECT/CT. FCH PET/CT leads more PHPT patients to correct imaging-guided MIP and normocalcemia than MIBI SPECT/CT due to its superior diagnostic accuracy.
Volume 99
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Endocrine Abstracts
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