Department of Nuclear Medicine and Thyroid Unit, Centre François Baclesse, Avenue Général Harris, F-14000, 14076, Caen cedex 5, France.
Department of Head & Neck Surgery, Centre François Baclesse, F-14000, Caen, France.
BMC Endocr Disord. 2021 Jan 7;21(1):3. doi: 10.1186/s12902-020-00667-5.
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. 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.
We 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.
FCH 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.
NCT04040946 , registered August 1, 2019. Protocol version Version 2.1 dated from 2020/04/23.
常见的内分泌疾病甲状旁腺功能亢进症（PHPT）可以通过手术治愈。通过影像学对甲状旁腺瘤（PTA）进行术前定位是门诊微创甲状旁腺切除术（MIP）的前提。与影像学不确定时进行的住院双侧颈探查（BCE）相比，MIP 在治愈率和并发症率方面更具优势，且成本更低。F18-胆碱（FCH）PET/CT 成像在 PTA 定位方面优于 Tc99m- sestamibi（MIBI）SPECT/CT，但费用要高得多。本研究旨在确定在不增加社会成本的情况下，用于 PHPT 患者最佳治疗的最有效的一线影像学方法。
我们将进行一项多中心开放诊断干预随机 III 期试验，比较 PHPT 患者的两种诊断策略：直接 FCH PET/CT 与 MIBI SPECT/CT。主要终点是一线影像学方法成功进行 MIP 和治愈的患者比例。术后 1 个月和 6 个月将进行包括生物检测在内的随访。主要次要终点是两种策略的社会成本。其他次要终点如下：FCH PET/CT 和 MIBI SPECT/CT 的诊断性能、手术程序和并发症发生率、FCH PET/CT 的观察者内和观察者间可变性以及 FCH PET/CT 程序的优化。将纳入 58 例患者并进行 1:1 随机分组。
FCH PET/CT 是一种高效但昂贵的术前 PTA 定位影像学检查，费用比 MIBI SPECT/CT 高 3 至 4 倍。FCH PET/CT 是否比参考标准 MIBI SPECT/CT 能改善患者预后尚不清楚。为了证明其附加成本的合理性，FCH PET/CT 引导的甲状旁腺手术应能改善患者管理，从而提高治愈率，减少 BCE 和手术并发症。在前瞻性 APACH1 研究中，我们发现，对于 MIBI SPECT/CT 阴性或不确定的患者，二线 FCH PET/CT 可使 88%的患者得到治愈。75%的患者可以避免 BCE，手术并发症发生率较低。因此，我们假设直接进行 FCH PET/CT 会改善 PHPT 患者的治疗效果，并且临床成本的降低将抵消影像学成本的增加。
NCT04040946，于 2019 年 8 月 1 日注册。协议版本：来自 2020 年 4 月 23 日的第 2.1 版。
