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Trial NCT07217704

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

Phase
Phase 3
Sponsor
SOFIE
Conditions
Esophageal Cancer; Gastric Cancer (GC); Gastroesophageal Junction
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * 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.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. Exclusion Criteria: * 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).Prior malignancy * Hepatic function: T. bili >1.5X ULN or alk phos, ALT, or AST >5X ULNHepatic * Renal function: GFR < 30 mL/minRenal * Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).Pregnancy * 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

Restrictions found (5)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County
  • UMass/Shields · Worcester, Worcester County