Esophageal CancerGastric Cancer (GC)Gastroesophageal Junction
Investigational drug(s) / intervention(s)
[18F]FAPI-74 PET/CT
[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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
* 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).
* 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
Primary outcome measure(s)
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference — 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
Trial sites (16)
Facility
City
Region
Status
Helios CR Inc./RadNet
Cerritos
California
Recruiting
City of Hope National Cancer Center
Duarte
California
Recruiting
Hoag Memorial Hospital
Irvine
California
Recruiting
UCLA
Los Angeles
California
Recruiting
Stanford University
Stanford
California
Recruiting
Moffit Cancer Center
Tampa
Florida
Recruiting
Indiana University Health University Hospital
Indianapolis
Indiana
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
UMass/Shields
Worcester
Massachusetts
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Recruiting
Icahn School of Medicine at Mount Sinai
New York
New York
Not Yet Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Kettering
Kettering
Ohio
Recruiting
University of Pennsylvania, Perelman School of Medicine
Philadelphia
Pennsylvania
Recruiting
Medical College of Wisconsin
Milwaukee
Wisconsin
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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