Surgical resolution of topographically diagnosed PHPT by 18F-choline PET/CT versus Tc99m sestaMIBI SPECT/TC: multicenter, randomized clinical trial

Abstract

BACKGROUND: Primary hyperthyroidism (PHPT) is a common endocrine disorder characterized by hypercalcemia and elevated or inappropriately normal parathyroid hormone (PTH) levels. The most frequent case of autonomous PTH production is solitary parathyroid adenoma in 80% of cases. Surgical treatment is the only definitive option for primary hyperparathyroidism. Once indicated, preoperative localization by nuclear medicine parathyroid imaging is a prerequisite before minimally invasive parathyroidectomy is performed. Negativity and/or discrepancy in first-line tests (ultrasound and parathyroid Tc-99m MIBI SPECT/CT) requires repeat imaging tests or requesting second-line tests such as Choline PET/CT. In recent years, 18F-choline PET/CT has demonstrated great utility for the detection of single or multiglandular disease, superior to first-line imaging tests. OBJECTIVE: The main objective of the work are: to compare the surgical results in post-parathyroidectomy patients with 18F-Choline PET/CT localization imaging test versus Tc99m-MIBI SPECT/TC and to study the impact that all this has on the surgical management of the process, analyzing the benefit/cost ratio. DESIGN AND SETTING: This scientific study is a multicenter, open-label, parallel-group, prospective, randomized, controlled , interventional clinical trial, performed in University Hospital Doctor Josep Trueta and University Hospital Vall d'Hebron. PARTICIPANTS: The study includes patients diagnosed with symptomatic primary hyperparathyroidism, or asymptomatic patients who meet criteria to be candidates for parathyroidectomy. METHODS: 120 patients will be recruited consecutively at the University Hospital Doctor Josep Trueta and the University Hospital Vall d'Hebron. They will be randomly divided into two groups, depending on the imaging test performed: A) In the first group Tc99m MIBI SPECT/, B) in the second group PET/CT with 18F-Coline will be performed. Subsequently, patients in both groups will undergo selective parathyroidectomy and the surgical results in the two groups will be compared. Subjects will be followed up for 1 and 6 months.