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Clinical Trial
. 2024 Aug 1;150(8):658-665.
doi: 10.1001/jamaoto.2024.1421.

F18-Choline PET/CT or MIBI SPECT/CT in the Surgical Management of Primary Hyperparathyroidism: A Diagnostic Randomized Clinical Trial

Elske Quak  1 , Audrey Lasne-Cardon  2 , Marie Cavarec  3 , Barbara Lireux  1 , Vianney Bastit  2   3 , Nathalie Roudaut  4 , Pierre-Yves Salaun  5   6 , Nathalie Keromnes  5 , Gaël Potard  7 , Patricia Vaduva  8 , Annabelle Esvant  8 , Franck Jegoux  9 , Olivier de Crouy-Chanel  9 , Anne Devillers  10 , Clémence Guery  10 , Charline Lasnon  1 , Renaud Ciappuccini  1 , Bérénice Legrand  11 , Adrien Estienne  11 , François Christy  11 , Jean-Michel Grellard  11 , Stéphane Bardet  1 , Bénédicte Clarisse  11
Affiliations
Clinical Trial

F18-Choline PET/CT or MIBI SPECT/CT in the Surgical Management of Primary Hyperparathyroidism: A Diagnostic Randomized Clinical Trial

Elske Quak et al. JAMA Otolaryngol Head Neck Surg. .

Abstract

Importance: Whether F18-choline (FCH) positron emission tomographic (PET)/computed tomographic (CT) scan can replace Tc99m-sestaMIBI (MIBI) single-photon emission (SPE)CT/CT as a first-line imaging technique for preoperative localization of parathyroid adenomas (PTA) in patients with primary hyperparathyroidism (PHPT) is unclear.

Objective: To compare first-line FCH PET/CT vs MIBI SPECT/CT for optimal care in patients with PHPT needing parathyroidectomy and to compare the proportions of patients in whom the first-line imaging method resulted in successful minimally invasive parathyroidectomy (MIP) and normalization of calcemia 1 month after surgery.

Design, setting, and participants: A French multicenter randomized open diagnostic intervention phase 3 trial was conducted. Patients were enrolled from November 2019 to May 2022 and participated up to 6 months after surgery. The study included adults with PHPT and an indication for surgical treatment. Patients with previous parathyroid surgery or multiple endocrine neoplasia type 1 (MEN1) were ineligible.

Interventions: Patients were assigned in a 1:1 ratio to receive first-line FCH PET/CT (FCH1) or MIBI SPECT/CT (MIBI1). In the event of negative or inconclusive first-line imaging, they received second-line FCH PET/CT (FCH2) after MIBI1 or MIBI SPECT/CT (MIBI2) after FCH1. All patients underwent surgery under general anesthesia within 12 weeks following the last imaging. Clinical and biologic (serum calcemia and parathyroid hormone levels) assessments were performed 1 and 6 months after surgery.

Main outcomes and measures: The primary outcome was a true-positive first-line imaging-guided MIP combined with uncorrected serum calcium levels of 2.55 mmol/l or less 1 month after surgery, corresponding to the local upper limit of normality.

Results: Overall, 57 patients received FCH1 (n = 29) or MIBI1 (n = 28). The mean (SD) age of patients was 62.8 (12.5) years with 15 male (26%) and 42 female (74%) patients. Baseline patient characteristics were similar between groups. Normocalcemia at 1 month after positive first-line imaging-guided MIP was observed in 23 of 27 patients (85%) in the FCH1 group and 14 of 25 patients (56%) in the MIBI1 group. Sensitivity was 82% (95% CI, 62%-93%) and 63% (95% CI, 42%-80%) for FCH1 and MIBI1, respectively. Follow-up at 6 months with biochemical measures was available in 43 patients, confirming that all patients with normocalcemia at 1 month after surgery still had it at 6 months. No adverse events related to imaging and 4 adverse events related to surgery were reported.

Conclusions: This randomized clinical trial found that first-line FCH PET/CT is a suitable and safe replacement for MIBI SPECT/CT. FCH PET/CT leads more patients with PHPT to correct imaging-guided MIP and normocalcemia than MIBI SPECT/CT thanks to its superior sensitivity.

Trial registration: ClinicalTrials.gov Identifier: NCT04040946.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Quak reported grants from Fondation de l’Avenir during the conduct of the study; personal fees from Novartis and Curium Pharma outside the submitted work. Dr Lasne-Cardon reported grants from Curium Pharma outside the submitted work. Mr Estienne reported grants from Fondation de l’Avenir during the conduct of the study. Dr Clarisse reported grants from Fondation de l’Avenir. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flowchart of Patients Through the Study
FCH1 indicates first-line F18-choline (FCH) positron emission tomographic (PET)/computed tomographic (CT) scan PET/CT; MIBI1, first-line Tc99m-sestaMIBI (MIBI) single-photon emission (SPE)CT/CTMIBI SPECT/CT, FCH PET/CT.
Figure 2.
Figure 2.. Proportion of Patients With Successful First-Line Imaging-Guided Mini-Invasive Parathyroidectomy and Normocalcemia at 1 Month After Surgery (Main End Point of the Study)
FCH PET/CT indicates F18-choline positron emission tomographic/computed tomographic scan; SPECT, single-photon emission CT.
Figure 3.
Figure 3.. First-Line F18-Choline (FCH) Positron Emission Tomography (PET)/Computed Tomography (CT) Images of a Patient With Primary Hyperparathyroidism (PHPT)
A, FCH PET maximum-intensity projection; B, FCH PET/CT fusion transverse slice; and C, low-dose CT transverse slice, showing high FCH uptake in an 11-mm left inferior PTA (arrowheads). The patient underwent minimally invasive parathyroidectomy, leading to normocalcemia during follow-up. No complications occurred.
Figure 4.
Figure 4.. Laboratory Results at Baseline, 1 Month, and 6 Months
FCH1 indicates first-line F18-choline (FCH) positron emission tomographic (PET)/computed tomographic (CT) scan PET/CT. Boxplots represent median, first and third quartiles, minimum (0 quartile) and maximum (fourth quartile) excluding outliers; the dots indicate outliers.
See this image and copyright information in PMC

References

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