NCT05262855已完成2 期
A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- SOFIE
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.
研究概览
简要总结
This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.
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
- •Pathologically confirmed pancreatic ductal adenocarcinoma
- •Treatment-naïve
- •Staged as resectable or borderline-resectable
- •Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
- •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
- •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 patient safety and/or protocol objectives.
- •Known diagnosis of autoimmune disorders
- •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 [68Ga]FAPI-46 injection.
- •Known hypersensitivity to any excipients used in [68Ga]FAPI-46:
- •trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid
研究组 & 干预措施
68Ga-FAPI-46 PET/CT
Experimental
Patients receive [68Ga]FAPI-46 intravenously followed by PET/CT 15-25 minutes later
干预措施: [68Ga]FAPI-46 (Drug)
结局指标
主要结局
Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.
时间窗: Through study completion, 2 years
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to 24 hours post injection with [68Ga]FAPI-46)
- Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.(Through study completion, 2 years)
- Histopathology with FAP staining on FAP IHC assay.(Through study completion, 2 years)
- [68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.(Through study completion, 2 years)
- [68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.(Through study completion for patient undergoing Neoadjuvant treatment, 2 years)
研究者
研究点 (8)
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