A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Gastric or Esophageal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- SOFIE
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
研究概览
简要总结
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such [¹⁸F]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of [¹⁸F]FAPI-74 PET/CT.
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
- •Male and female adults ≥ 18 years.
- •Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Provided signed, written informed consent prior to any study-related procedures.
- •Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of [¹⁸F]FAPI-74 administration.
- •For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, during the trial intervention period.
排除标准
- •Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
- •Known hypersensitivity to [¹⁸F]FAPI-
- •Administration of another investigational diagnostic or therapeutic product within 30 days prior to [¹⁸F]FAPI-74 administration.
- •Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of [¹⁸F]FAPI-74 administration.
- •Previous cancer (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus (participants treated with curative intent and disease free for more than 5 years are permitted).
- •Hepatic function: T. bili >1.5X ULN or alk phos, ALT, or AST >5X ULN
- •Renal function: GFR < 30 mL/min
- •Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).
- •Inability to undergo the PET/CT scanning procedure.
- •Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- •Sarcoidosis
- •Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers
研究组 & 干预措施
Patients with gastric or esophageal cancer receiving [18F]FAPI-74
干预措施: [18F]FAPI-74 PET/CT (Drug)
结局指标
主要结局
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
时间窗: From enrollment to the end of treatment after 3 month follow up
To evaluate the diagnostic performance of \[¹⁸F\]FAPI-74 in determining the presence or absence of metastatic disease (M1) in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancers, compared to a composite SOT
次要结局
- Incidence and severity of adverse events using CTCAE v5.(24-72 hours post-injection)
- Sensitivity and specificity for the localized detection of peritoneal metastases(From enrollment to the end of treatment after 3 month follow up)
- Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference(From enrollment to the end of treatment after 3 month follow up)
- Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement(From enrollment to the end of treatment after 3 month follow up)
- Number of participants with treatment-related adverse events as assessed by body temperature changes(24-72 hours post-injection)
- Number of participants with treatment-related adverse events as assessed by blood pressure changes(24-72 hours post-injection)
- Number of participants with treatment-related adverse events as assessed by respiration rate(Time Frame: 24-72 hours post-injection)
- Number of participants with treatment-related adverse events as assessed by pulse rate(24-72 hours post-injection)