A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- SOFIE
- 入组人数
- 109
- 试验地点
- 6
- 主要终点
- Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
研究概览
简要总结
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.
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
- •Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
- •Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
- •No treatment received between tissue sample taken and [18F]FAPI-74 PET
- •Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
- •Age ≥ 18 years
- •Completed informed consent as determined per the IRB of record
排除标准
- •Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- •Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
- •Need for emergent surgery that would be delayed by participation
- •Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
- •Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
- •Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
- •Patients receiving any other investigational agent within the past 28 days
- •Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FAPI-74 injection
- •Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
- •Renal or liver function impairment* *Defined by liver impairments as AST>3x the upper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of >1.5x the upper limit of normal utilizing the Cockcroft Gault formula
研究组 & 干预措施
[18F]FAPI-74 PET/CT
Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
干预措施: [18F]FAPI-74 PET/CT (Drug)
结局指标
主要结局
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
时间窗: Through study completion, 2 years
Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging
次要结局
- Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.(Through study completion, 2 years)
- Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)(Through study completion, 2 years)