Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer

Официальное название

Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET/CT in Recurrent and Metastatic Thyroid Cancer and Compared With 68Ga-FAPI PET/CT

Обзор

In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT (68Ga-MY6349 PET/CT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 68Ga-FAPI PET/CT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 68Ga-FAPI PET/CT, and the impact on clinical management.

Подробное описание

Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we evaluated the diagnostic performance of 68Ga-MY6349 PET/CT in recurrent and metastatic thyroid cancer and compared it with 18F-FDG PET/CT. The results demonstrated that 68Ga-MY6349 PET/CT was superior to 18F-FDG PET/CT for lesion detection, particularly in patients with PTC and TENIS. In addition, fibroblast activation protein is highly expressed in cancer-associated fibroblasts in thyroid cancer. 68Ga-labeled FAP inhibitor (FAPI) has demonstrated favorable in vivo pharmacokinetics and higher diagnostic accuracy than 18F-FDG in various types of cancers, including thyroid cancer.

In this study, we comprehensively evaluated the clinical utility of 68Ga-MY6349 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with 68Ga-FAPI PET/CT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 68Ga-FAPI PET/CT, and the impact on clinical management.

Вмешательства

• Диагностический тест Compared the diagnostic performance of 68Ga-MY6349 PET/CT with 68Ga-FAPI PET/CT
  Each subject receives a single intravenous injection of 68Ga-MY6349 and 68Ga-FAPI and undergoes PET/CT imaging within the specified time. For participants who were not radioiodine-refractory or who did not have MTC or ATC, DxWBS was conducted. Each participant received an intramuscular injection of rhTSH on two consecutive days, followed by the oral administration of 131I. DxWBS was performed 2 days after 131I administration

Первичные конечные точки

• Diagnostic performance (patient-based) [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Diagnostic performance (patient-based) [Срок оценки: 2 years]
• Diagnostic performance [Срок оценки: 2 years]
• SUVmax and TBR [Срок оценки: 2 years]
• The impact on clinical management [Срок оценки: 2-4 weeks]

Критерии участия

Критерии включения

• Adult patients (aged 18 years or older);
• Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng/mL after 131I ablation or ≥5 ng/mL without ablation) with negative anti thyroglobulin antibodies (<20 IU/mL) for DTC and HGFCTC or elevated calcitonin (>10 pg/mL) for MTC;
• Patients who had scheduled both 68Ga-MY6349 and 68Ga-FAPI PET/CT scans;
• Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
• No other anticancer therapy within four weeks prior to PET imaging.

Критерии исключения

• Pregnant or lactating patients;
• Patients with a second primary tumor;
• The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000 — Xiamen

Идентификаторы

NCT: NCT07753499 · XMYY-2026KY052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗