Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSOFIE
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. 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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
[18F]FAPI-74 PET/CT
Drug\[18F\]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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients with gastric or esophageal cancer receiving [18F]FAPI-74Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
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
Time frame
From enrollment to the end of treatment after 3 month follow upSecondary outcomes
1
Incidence and severity of adverse events using CTCAE v5.
To assess the safety profile of \[¹⁸F\]FAPI-74.
Time frame
24-72 hours post-injection2
Sensitivity and specificity for the localized detection of peritoneal metastases
To evaluate the diagnostic performance of \[18F\]FAPI-74 PET/CT for detecting peritoneal metastatic disease
Time frame
From enrollment to the end of treatment after 3 month follow up3
Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference
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.
Time frame
From enrollment to the end of treatment after 3 month follow up4
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
Time frame
From enrollment to the end of treatment after 3 month follow up Source ClinicalTrials.gov