PDF(Pubmed)
Abstract：
BACKGROUND: [18F]Fluorodeoxyglucose ([18F]FDG) positron emission tomography (PET) is recommended during diagnostic work-up for ovarian cancer; however, [18F]FDG PET has several inherent limitations. The novel oncologic PET-tracer fibroblast activation protein inhibitor (FAPI) has demonstrated promising results in multiple cancer types, including ovarian cancer, and could overcome the limitations of [18F]FDG PET; however, high-quality clinical studies are lacking. The primary objective of the present study is to compare the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT and [18F]FDG PET/CT in ovarian cancer patients and to investigate how this potential difference impacts staging and patient management.
METHODS: Fifty consecutive ovarian cancer patients will be recruited from Aalborg University Hospital, Denmark. This study will be a single-center, prospective, exploratory clinical trial that adheres to the standards for reporting diagnostic accuracy studies (STARD). This study will be conducted under continuous Good Clinical Practice monitoring. The eligibility criteria for patients are as follows: (1) biopsy verified newly diagnosed ovarian cancer or a high risk of ovarian cancer and referred for primary staging with [18F]FDG PET/CT; and (2) resectable disease, i.e., candidate for primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery. All recruited study subjects will undergo [68Ga]Ga-FAPI-46 PET/CT at primary staging, before primary debulking surgery or neoadjuvant chemotherapy (Group A + B), in addition to conventional imaging (including [18F]FDG PET/CT). Study subjects in Group B will undergo an additional [68Ga]Ga-FAPI-46 PET/CT following neoadjuvant chemotherapy prior to interval debulking surgery. The results of the study-related [68Ga]Ga-FAPI-46 PET/CTs will be blinded, and treatment allocation will be based on common clinical practice in accordance with current guidelines. The histopathology of surgical specimens will serve as a reference standard. A recruitment period of 2 years is estimated; the trial is currently recruiting.
CONCLUSIONS: To our knowledge, this trial represents the largest, most extensive, and most meticulous prospective FAPI PET study conducted in patients with ovarian cancer thus far. This study aims to obtain a reliable estimation of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT, shed light on the clinical importance of [68Ga]Ga-FAPI-46 PET/CT, and examine the potential applicability of [68Ga]Ga-FAPI-46 PET/CT for evaluating chemotherapy response.
BACKGROUND: clinicaltrials.gov: NCT05903807, 2nd June 2023; and euclinicaltrials.eu EU CT Number: 2023-505938-98-00, authorized 11th September 2023.
METHODS: Fifty consecutive ovarian cancer patients will be recruited from Aalborg University Hospital, Denmark. This study will be a single-center, prospective, exploratory clinical trial that adheres to the standards for reporting diagnostic accuracy studies (STARD). This study will be conducted under continuous Good Clinical Practice monitoring. The eligibility criteria for patients are as follows: (1) biopsy verified newly diagnosed ovarian cancer or a high risk of ovarian cancer and referred for primary staging with [18F]FDG PET/CT; and (2) resectable disease, i.e., candidate for primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery. All recruited study subjects will undergo [68Ga]Ga-FAPI-46 PET/CT at primary staging, before primary debulking surgery or neoadjuvant chemotherapy (Group A + B), in addition to conventional imaging (including [18F]FDG PET/CT). Study subjects in Group B will undergo an additional [68Ga]Ga-FAPI-46 PET/CT following neoadjuvant chemotherapy prior to interval debulking surgery. The results of the study-related [68Ga]Ga-FAPI-46 PET/CTs will be blinded, and treatment allocation will be based on common clinical practice in accordance with current guidelines. The histopathology of surgical specimens will serve as a reference standard. A recruitment period of 2 years is estimated; the trial is currently recruiting.
CONCLUSIONS: To our knowledge, this trial represents the largest, most extensive, and most meticulous prospective FAPI PET study conducted in patients with ovarian cancer thus far. This study aims to obtain a reliable estimation of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT, shed light on the clinical importance of [68Ga]Ga-FAPI-46 PET/CT, and examine the potential applicability of [68Ga]Ga-FAPI-46 PET/CT for evaluating chemotherapy response.
BACKGROUND: clinicaltrials.gov: NCT05903807, 2nd June 2023; and euclinicaltrials.eu EU CT Number: 2023-505938-98-00, authorized 11th September 2023.
摘要：
背景：[18F]氟脱氧葡萄糖（[18F]FDG）正电子发射断层扫描（PET）建议在卵巢癌的诊断检查中进行；然而，[18F]FDGPET具有几个固有的局限性。新型肿瘤PET-示踪剂成纤维细胞活化蛋白抑制剂（FAPI）已在多种癌症类型中证明了有希望的结果，包括卵巢癌,并且可以克服[18F]FDGPET的局限性；然而，缺乏高质量的临床研究。本研究的主要目的是比较[68Ga]Ga-FAPI-46PET/CT和[18F]FDGPET/CT在卵巢癌患者中的诊断准确性，并研究这种潜在差异如何影响分期和患者管理。
方法：将从奥尔堡大学医院招募50名连续的卵巢癌患者，丹麦。这项研究将是一个单中心，prospective,符合诊断准确性研究报告标准的探索性临床试验(STARD)。这项研究将在持续的良好临床实践监测下进行。患者的资格标准如下：（1）活检证实的新诊断卵巢癌或卵巢癌的高风险，并使用[18F]FDGPET/CT进行原发性分期；（2）可切除的疾病，即，初次减瘤手术或新辅助化疗，然后进行间隔减瘤手术的候选人。所有招募的研究对象将在主要分期接受[68Ga]Ga-FAPI-46PET/CT，在初次减瘤手术或新辅助化疗之前（A+B组），除了常规成像（包括[18F]FDGPET/CT）。B组中的研究受试者将在新辅助化疗后在间隔减积手术之前接受额外的[68Ga]Ga-FAPI-46PET/CT。研究相关的[68Ga]Ga-FAPI-46PET/CT的结果将是盲的，和治疗分配将根据当前指南的常规临床实践。手术标本的组织病理学将作为参考标准。预计招募期为2年；目前正在进行招募。
结论：据我们所知，这次审判是最大的一次，最广泛的，以及迄今为止在卵巢癌患者中进行的最细致的前瞻性FAPIPET研究。本研究旨在获得对[68Ga]Ga-FAPI-46PET/CT的诊断准确性的可靠估计，阐明[68Ga]Ga-FAPI-46PET/CT的临床重要性，并检查[68Ga]Ga-FAPI-46PET/CT用于评估化疗反应的潜在适用性。
背景：clinicaltrials.gov：NCT05903807，2023年6月2日；和euclinicaltrials。欧盟CT编号：2023-505938-98-00，授权2023年9月11日。
方法：将从奥尔堡大学医院招募50名连续的卵巢癌患者，丹麦。这项研究将是一个单中心，prospective,符合诊断准确性研究报告标准的探索性临床试验(STARD)。这项研究将在持续的良好临床实践监测下进行。患者的资格标准如下：（1）活检证实的新诊断卵巢癌或卵巢癌的高风险，并使用[18F]FDGPET/CT进行原发性分期；（2）可切除的疾病，即，初次减瘤手术或新辅助化疗，然后进行间隔减瘤手术的候选人。所有招募的研究对象将在主要分期接受[68Ga]Ga-FAPI-46PET/CT，在初次减瘤手术或新辅助化疗之前（A+B组），除了常规成像（包括[18F]FDGPET/CT）。B组中的研究受试者将在新辅助化疗后在间隔减积手术之前接受额外的[68Ga]Ga-FAPI-46PET/CT。研究相关的[68Ga]Ga-FAPI-46PET/CT的结果将是盲的，和治疗分配将根据当前指南的常规临床实践。手术标本的组织病理学将作为参考标准。预计招募期为2年；目前正在进行招募。
结论：据我们所知，这次审判是最大的一次，最广泛的，以及迄今为止在卵巢癌患者中进行的最细致的前瞻性FAPIPET研究。本研究旨在获得对[68Ga]Ga-FAPI-46PET/CT的诊断准确性的可靠估计，阐明[68Ga]Ga-FAPI-46PET/CT的临床重要性，并检查[68Ga]Ga-FAPI-46PET/CT用于评估化疗反应的潜在适用性。
背景：clinicaltrials.gov：NCT05903807，2023年6月2日；和euclinicaltrials。欧盟CT编号：2023-505938-98-00，授权2023年9月11日。
