Esophageal Cancer, Gastric Cancer (GC), Gastroesophageal Junction
Conditions
Keywords
FAP, Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, gastroesophageal cancer, PET
Brief 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.
Interventions
\[18F\]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.
Sponsors
SOFIE
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events using CTCAE v5. | 24-72 hours post-injection | To assess the safety profile of \[¹⁸F\]FAPI-74. |
| Sensitivity and specificity for the localized detection of peritoneal metastases | From enrollment to the end of treatment after 3 month follow up | To evaluate the diagnostic performance of \[18F\]FAPI-74 PET/CT for detecting peritoneal metastatic disease |
| Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference | From enrollment to the end of treatment after 3 month follow up | To compare clinical accuracy of \[18F\]FAPI-74 PET/CT imaging to that of \[¹⁸F\]FDG PET/CT, for participants who have had this performed, for detection of metastatic disease. |
| Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement | From enrollment to the end of treatment after 3 month follow up | To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease |
| Number of participants with treatment-related adverse events as assessed by body temperature changes | 24-72 hours post-injection | To assess the safety profile of \[¹⁸F\]FAPI-74 |
| Number of participants with treatment-related adverse events as assessed by blood pressure changes | 24-72 hours post-injection | To assess the safety profile of \[¹⁸F\]FAPI-74 |
| Number of participants with treatment-related adverse events as assessed by respiration rate | Time Frame: 24-72 hours post-injection | To assess the safety profile of \[¹⁸F\]FAPI-74 |
| Number of participants with treatment-related adverse events as assessed by pulse rate | 24-72 hours post-injection | To assess the safety profile of \[¹⁸F\]FAPI-74 |
Countries
United States
Contacts
CONTACTAlex Osipova
CONTACTBridget Adams
STUDY_DIRECTORSherly Mosessian, Ph.D
SOFIE
Outcome results
None listed