Covalent FAPI Imaging–Guided Precision Surgery in Patients with Medullary Thyroid Carcinoma: A Phase II Clinical Trial
Abstract
Abstract Purpose: Medullary thyroid carcinoma (MTC) is curable only by complete resection of all malignant lesions; however, biochemical cure rates remain suboptimal because of 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 [68Ga]Ga-CTR-FAPI-30 positron emission tomography–computed tomography (PET-CT)–guided surgery improves patient outcomes. Patients and Methods: In this prospective, open-label phase II clinical trial, 50 patients with MTC were enrolled and underwent [68Ga]Ga-CTR-FAPI-30 PET-CT–guided surgery. Patients were stratified into three predefined arms: (i) newly diagnosed MTC, R0 resection; (ii) recurrent MTC, R0 resection; and (iii) 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 [68Ga]Ga-CTR-FAPI-30, and surgical plan modification rate. Results: The biochemical cure rates were favorable under [68Ga]Ga-CTR-FAPI-30–guided surgery, with 84.2% [95% confidence interval (CI), 60.4%–96.6%] in arm 1 (newly diagnosed, R0 resection) and 46.7% (95% CI, 21.3%–73.4%) in arm 2 (recurrent, R0 resection), both of which exceeded historical data (P = 0.007–0.049). For 231 lesions with gold-standard pathology, [68Ga]Ga-CTR-FAPI-30 demonstrated superior diagnostic…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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