Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Purpose
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.
Conditions
- Esophageal Cancer
- Gastric Cancer (GC)
- Gastroesophageal Junction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients with gastric or esophageal cancer receiving [18F]FAPI-74 |
|
Recruiting Locations
Cerritos 5335663, California 5332921 90703
Irvine 5359777, California 5332921 92618
More Details
- Status
- Recruiting
- Sponsor
- SOFIE