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
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)
- HepaticOutrightexclusion
T. bili > 1.5X ULN; ALT or AST > 5X ULN
Show in the text - Performance statusOutrightinclusion
ECOG <= 2
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
disease free for more than 5 years
Show in the text - RenalOutrightexclusion
GFR < 30 mL/min
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- UMass/Shields · Worcester, Worcester County