PO.CT01.04 · 临床试验

共价FAPI成像引导的甲状腺髓样癌精准手术

Covalent FAPI imaging-guided precision surgery in medullary thyroid carcinoma

编号 CT242 展板 7 时间 4/21 02:00–05:00 区域 Section 50 主讲 Ziren Kong, MD

分会场 Phase II Clinical Trials

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作者与单位 Authors & Affiliations

Ziren Kong¹, Yang Liu¹, Yan-Song Lin², Zhu Li³, Xi-Yang Cui⁴, Shengyan Liu², Xin Zhang², Ruochen Li², Ye Yang¹, Yuning Sun¹, Yongdu Nie¹, Zongmin Zhang¹, Changming An¹, Song Ni¹, Yiming Zhu¹, Zhibo Liu⁵, Jian Wang¹, Shaoyan Liu¹

¹Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China,²Peking Union Medical College Hospital, Beijing, China,³Peking University Cancer Hospital, Beijing, China,⁴Changping Laboratory, Beijing, China,⁵Peking University, Beijing, China

摘要 Abstract

中文摘要

目的：甲状腺髓样癌（MTC）只有完全切除所有恶性病灶才能治愈；然而，由于病灶定位不精确，生化治愈率仍不理想。我们此前开发了一种共价靶向放射配体成纤维细胞活化蛋白抑制剂（CTR-FAPI-30），具有更高的MTC检测率和准确性。本研究评估[68Ga]Ga-CTR-FAPI-30 PET-CT引导手术是否能改善患者预后。患者与方法：在这项前瞻性、开放标签的II期临床试验中，共入组50例MTC患者并接受[68Ga]Ga-CTR-FAPI-30 PET-CT引导手术。患者被分层为3个预先设定的组别：1）新诊断MTC，R0切除；2）复发MTC，R0切除；3）不可切除疾病或远处转移。主要终点为术后1个月的生化治愈率。次要终点包括无事件生存期、[68Ga]Ga-CTR-FAPI-30的诊断准确性以及手术方案修改率。结果：各组的基线特征（人口统计学、T分期、N分期、术前降钙素）与大规模回顾性研究的历史数据相当（p=0.120-0.948）。与历史数据相比，[68Ga]Ga-CTR-FAPI-30引导手术下的生化治愈率更高，第1组（新诊断，R0切除）为84.2%（95% CI，60.4%-96.6%）对57.9%（p=0.007），第2组（持续性，R0切除）为46.7%（95% CI，21.3%-73.4%）对16.2%-17.9%（p=0.038-0.049）。第3组未发生生化治愈。对于231个具有金标准病理的病灶，[68Ga]Ga-CTR-FAPI-30较传统影像学表现出更优的诊断准确性（96.5%对72.7%，p<0.0001）、灵敏度（98.5%对81.7%，p<0.0001）和特异度（85.3%对20.6%，p<0.0001）。与研究者确定的方案相比，46%的患者基于[68Ga]Ga-CTR-FAPI-30 PET-CT修改了手术方案，其中91%的修改在组织病理学上得到证实。结论：[68Ga]Ga-CTR-FAPI-30引导手术对新诊断和复发MTC均实现了良好的生化治愈率，通过精确的病灶定位实现了精准的手术切除。结合其相对传统影像学已确立的诊断优势，[68Ga]Ga-CTR-FAPI-30 PET-CT代表了一种有前景的MTC初始分期和手术规划的标准治疗工具。

查看英文原文 English abstract

Purpose: Medullary thyroid carcinoma (MTC) is curable only by complete resection of all malignant lesions; however, biochemical cure rates remain suboptimal due to imprecise lesion localization. We previously developed a covalent targeted radioligand fibroblast activation protein inhibitor (CTR-FAPI-30) with superior MTC detection rate and accuracy. This study evaluated whether [ 68 Ga]Ga-CTR-FAPI-30 PET-CT-guided surgery improves patient outcomes. Patients and methods: In this prospective, open-label phase II clinical trial, 50 MTC patients were enrolled and underwent [ 68 Ga]Ga-CTR-FAPI-30 PET-CT-guided surgery. Patients were stratified into 3 pre-defined arms: 1) newly-diagnosed MTC, R0 resection; 2) recurrent MTC, R0 resection; 3) unresectable disease or distant metastasis. The primary endpoint was the biochemical cure rate at 1-month postoperatively. Secondary endpoints included event free survival, the diagnostic accuracy of [ 68 Ga]Ga-CTR-FAPI-30, and surgical plan modification rate. Results: Baseline characteristics (demographics, T staging, N staging, preoperative calcitonin) of each arm were comparable to historical data from large-scale retrospective studies (p=0.120-0.948). The biochemical cure rates were higher under [ 68 Ga]Ga-CTR-FAPI-30-guided surgery compared to historical data, with 84.2% (95% CI, 60.4%-96.6%) vs. 57.9% (p=0.007) in Arm 1 (newly diagnosed, R0 resection) and 46.7% (95% CI, 21.3%-73.4%) vs. 16.2%-17.9% (p=0.038-0.049) in Arm 2 (persistent, R0 resection). No biochemical cure occurred in Arm 3. For 231 lesions with gold-standard pathology, [ 68 Ga]Ga-CTR-FAPI-30 demonstrated superior diagnostic accuracy (96.5% vs. 72.7%, p<0.0001), sensitivity (98.5% vs. 81.7%, p<0.0001), and specificity (85.3% vs. 20.6%, p<0.0001) compared to conventional imaging. Surgical plans were modified in 46% of patients based on [ 68 Ga]Ga-CTR-FAPI-30 PET-CT compared to investigator determined approaches, with 91% of these modifications were histopathologically justified. Conclusions: [ 68 Ga]Ga-CTR-FAPI-30-guided surgery achieved favorable biochemical cure rates for both newly diagnosed and recurrent MTC, enabling precision surgical resection through accurate lesion localization. Combined with its established diagnostic superiority over conventional imaging, [ 68 Ga]Ga-CTR-FAPI-30 PET-CT represents a promising standard-of-care tool for initial staging and surgical planning in MTC.

利益披露 Disclosure

Z. Kong, None.. Y. Liu, None.. Y. Lin, None.. Z. Li, None.. X. Cui, None.. S. Liu, None.. X. Zhang, None.. R. Li, None.. Y. Yang, None.. Y. Sun, None.. Y. Nie, None.. Z. Zhang, None.. C. An, None.. S. Ni, None.. Y. Zhu, None.. Z. Liu, None.. J. Wang, None.. S. Liu, None.

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