[68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing diagnostic workup (including FDG PET/CT) at primary staging and restaging.
The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.
详细描述
A new and promising PET-tracer in oncology has been developed; Gallium-68 labelled fibroblast activation protein inhibitor (FAPI). In general, FAPI PET/CT delivers increased sensitivity compared to 18F-Fluorodeoxyglucose (FDG) PET/CT in cancer types of mesenchymal origin (i.e., sarcomas), and in cancers characterized by a large proportion of stromal cells such as gastric and pancreatic cancers. It is currently debated whether FAPI PET/CT will take over FDG PET/CTs well-established role in oncological PET/CT, but more studies are needed to evaluate the diagnostic accuracy. The clinical interest in FAPI extends beyond the use as a diagnostic tool, as the 68Ga-isotope can be replaced by a β-emitting isotope, e.g., 177-Lu or 90-Y, enabling radionuclide therapy of FAPI-avid cancers.
In recent comparative studies of FDG- and FAPI PET/CT, all primary tumors of the stomach were detected on FAPI PET, whereas the reported detection rate on FDG PET ranged from 40% to 86%. Regarding metastases, FAPI PET/CT showed comparable or better detection rate for regional lymph nodes, but outperformed FDG PET/CT in the detection of peritoneal and other distant metastases. Re-staging with FAPI PET after chemotherapy has been attempted in only a handful of patients and seems feasible.
Even though the results of FAPI PET/CT compared to conventional imaging seem convincing, there are several limitations and therefore FAPI PET/CT is not yet implemented in cancer diagnostics.
The investigators are conducting a prospective explorative study complying with the Standard for Reporting Diagnostic Accuracy (STARD) criteria where 20 patients with gastric cancer or gastro-eophageal junctional cancer are recruited.
Study subject will undergo FAPI PET/CT at primary staging (before treatment, i.e., neoadjuvant chemotherapy or surgery) and at restaging (after neoadjuvant chemotherapy - before surgery) in addition to routing diagnostic workup (including FDG PET/CT). The FAPI PET/CT will be blinded and the choice of treatment will not be influence by the FAPI PET/CT results'. The additional scans will not interfere with or delay routine diagnostic workup or treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with biopsy verified gastric or GEJ cancer and referred to primary staging FDG PET/CT
- •Deemed resectable and operable at the MDT, with or without neoadjuvant chemotherapy
- •Considered physically and mentally able to participate in the research project
- •Can read and understand Danish
- •18-years or older and able to consent to project participation
排除标准
- •Patients with non-resectable, inoperable, or recurrent gastric or GEJ cancer
- •Patients with an imminent need for surgery or in an emergency
- •Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer
- •Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
- •Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
- •History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-
- •Severe claustrophobia unresponsive to oral anxiolytics
- •Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
- •Pregnant, lactating, or breastfeeding women.
- •Potential pregnant women of childbearing potential[1] not using effective contraceptives[2]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG) or serum HCG) < 48 hours before injection with 68Ga-FAPI-
- •Inability to remain still for the duration of the examination
- •Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed.
- •Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).
研究组 & 干预措施
Gastric or gastro-esophageal junctioncancer
Patients with biopsy verified gastric or gastro-esophageal junction cancer undergo FAPI PET/CT in addition to conventional imaging
干预措施: 68Ga-FAPi-46 (Drug)
结局指标
主要结局
Diagnostic accuracy
时间窗: 1.5 years
Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, positive predicative value, and negative predicative values of the PET/CTs are determined, both at primary staging and at restaging
Staging
时间窗: 1.5 years
Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging and at restaging (after neoadjuvant chemotherapy). The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/CT are determined.
Patient management
时间窗: 1.5 - 2 years
Investigate what proportion of patients will be (hypothetically) treated differently due to an added FAPI PET/CT at primary staging and at restaging (after neoadjuvant chemotherapy) by the treating clinicians
次要结局
- Uptake values(1.5 years)
- Chemotherapy effect on uptake values(1.5 - 2 years)
- Unexpected FAPI PET/CT findings(1 -2 years)
- Interobserver readability(4 years)
- Prognostic value(10 years)
研究者
Morten Bentestuen
Principal Investigator
Aalborg University Hospital