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Using 18F-FAPI PET for Gastric and Esophageal Cancer

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

Recruiting Phase 3 Interventional Study

Esophageal Cancer Gastric Cancer (GC) Gastroesophageal Junction

No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.

At a Glance

Age: 18 and older
Sex: Any
Trial phase: Phase 3
Study type: Interventional
Purpose: Diagnostic
Participants needed: 200 (estimated)
Sponsor: SOFIE · Industry

Who this trial is looking for

This trial is looking for adults with gastric, esophageal, or gastroesophageal cancer who are evaluating their treatment options. Participants will receive a PET scan with a special substance to help detect cancer spread.

Are You a Good Fit for This Trial?

You may be able to join if

I am an adult aged 18 years or older.
I have been diagnosed with gastric, esophageal, or gastroesophageal cancer.
I am undergoing an evaluation for treatment planning.
I have a good performance status (ECOG ≤2).
I have signed a consent form for the study.
I have had a CT scan of my chest, abdomen, and pelvis within the last 21 days or plan to have one before the PET scan.
I will use effective contraception if I am a woman of childbearing potential.

You may not be able to join if

I have clear evidence of cancer spreading that prevents surgery as an option.
I am allergic to 18F-FAPI-74.
I have taken another investigational treatment in the last 30 days.
I have had a radiopharmaceutical in the last 10 half-lives before this study.
I have had another type of cancer recently, except for certain skin cancers.
My liver function results are outside the normal range.
My kidney function is poor (GFR < 30 mL/min).
I am pregnant or currently breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility

About This Trial

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. …

Trial Locations

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Eligibility Criteria

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

Contacts

Alex Osipova

1-800-753-5368

Alex.osipova@sofie.com

CONTACT

Bridget Adams