Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

Официальное название

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

Обзор

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.

Вмешательства

• Препарат [18F]FAPI-74 PET/CT
  \[18F\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastric or esophageal cancers.

Первичные конечные точки

• Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference [Срок оценки: From enrollment to the end of treatment after 3 month follow up]

Вторичные конечные точки (8)

• Incidence and severity of adverse events using CTCAE v5. [Срок оценки: 24-72 hours post-injection]
• Sensitivity and specificity for the localized detection of peritoneal metastases [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment after 3 month follow up]
• Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement [Срок оценки: 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 [Срок оценки: 24-72 hours post-injection]
• Number of participants with treatment-related adverse events as assessed by blood pressure changes [Срок оценки: 24-72 hours post-injection]
• Number of participants with treatment-related adverse events as assessed by respiration rate [Срок оценки: Time Frame: 24-72 hours post-injection]
• Number of participants with treatment-related adverse events as assessed by pulse rate [Срок оценки: 24-72 hours post-injection]

Критерии участия

Критерии включения

• 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 ≤2.
• 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.

Критерии исключения

• Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
• Known hypersensitivity to \[¹⁸F\]FAPI-74.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 15 центров

• Helios CR Inc./RadNet — Cerritos
• City of Hope National Cancer Center — Duarte
• Hoag Memorial Hospital — Irvine
• UCLA — Los Angeles
• Stanford University — Stanford
• Moffit Cancer Center — Tampa
• Indiana University Health University Hospital — Indianapolis
• Massachusetts General Hospital — Boston
• … и ещё 7 центров

Идентификаторы

NCT: NCT07217704 · 18FFAPI-2025P3-GEC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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