Abstract
BackgroundThe common endocrine disorder primary hyperparathyroidism (PHPT) can be cured by surgery. Preoperative localization of parathyroid adenoma (PTA) by imaging is a prerequisite for outpatient minimally invasive parathyroidectomy (MIP). Compared to inpatient bilateral cervical exploration (BCE) which is performed if imaging is inconclusive, MIP is superior in terms of cure and complication rates and less costly. The imaging procedure F18-choline (FCH) PET/CT outperforms Tc99m-sestaMIBI (MIBI) SPECT/CT for PTA localization, but it is much costlier. The aim of this study is to identify the most efficient first-line imaging modality for optimal patient care in PHPT without added cost to society.MethodsWe will conduct a multicenter open diagnostic intervention randomized phase III trial comparing two diagnostic strategies in patients with PHPT: upfront FCH PET/CT versus MIBI SPECT/CT. The primary endpoint is the proportion of patients in whom the first-line imaging method results in successful MIP and cure. Follow-up including biological tests will be performed 1 and 6 months after surgery. The main secondary endpoint is the social cost of both strategies. Other secondary endpoints are as follows: FCH PET/CT and MIBI SPECT/CT diagnostic performance, performance of surgical procedure and complication rate, FCH PET/CT inter- and intra-observer variability and optimization of FCH PET/CT procedure. Fifty-eight patients will be enrolled and randomized 1:1.DiscussionFCH PET/CT is a highly efficient but expensive imaging test for preoperative PTA localization and costs three to four times more than MIBI SPECT/CT. Whether FCH PET/CT improves patient outcomes compared to the reference standard MIBI SPECT/CT is unknown. To justify its added cost, FCH PET/CT-guided parathyroid surgery should lead to improved patient management, resulting in higher cure rates and fewer BCEs and surgical complications.In the previous phase II APACH1 study, we showed that second-line FCH PET/CT led to a cure in 88% of patients with negative or inconclusive MIBI SPECT/CT. BCE could be avoided in 75% of patients and surgical complication rates were low. We therefore hypothesize that upfront FCH PET/CT would improve patient care in PHPT and that the reduction in clinical costs would offset the increase in imaging costs.Trial registrationNCT04040946, registered August 1, 2019. Protocol versionVersion 2.1 dated from 2020/04/23.
Highlights
The common endocrine disorder primary hyperparathyroidism (PHPT) can be cured by surgery
Whether FCH PET/Computed tomography (CT) improves patient outcomes compared to the reference standard MIBI SPECT/CT is unknown
In the previous phase II APACH1 study, we showed that second-line FCH Positron emission tomography/computed tomography (PET/CT) led to a cure in 88% of patients with negative or inconclusive MIBI SPECT/CT
Summary
The common endocrine disorder primary hyperparathyroidism (PHPT) can be cured by surgery. Preoperative localization of parathyroid adenoma (PTA) by imaging is a prerequisite for outpatient minimally invasive parathyroidectomy (MIP). Compared to inpatient bilateral cervical exploration (BCE) which is performed if imaging is inconclusive, MIP is superior in terms of cure and complication rates and less costly. Primary hyperthyroidism (PHPT) is a common endocrine disorder characterized by hypercalcemia and elevated or inappropriately normal parathyroid hormone (PTH) levels. With the advent of preoperative PTA localization by medical imaging, conventional inpatient bilateral cervical exploration (BCE) is tending to be replaced by minimally invasive surgery (MIP). MIP has superior cure and complication rates compared to BCE and is less costly [2]. One of the most frequently used 3D imaging techniques for PTA localization is parathyroid scintigraphy including SPECT/CT acquisition. Parathyroid SPECT/CT with the tracer Tc99msestaMIBI (MIBI) led to PTA detection in about twothirds of patients, meaning that BCE or active surveillance was proposed to one-third of patients [10]
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