Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
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 pancreatic ductal adenocarcinoma. 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 PDAC, undergoing staging evaluation for treatment planning.
Provided signed, written informed consent obtained 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.
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 therapeutic or diagnostic 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 pancreatic ductal adenocarcinoma.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients with pancreatic ductal adenocarcinoma 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 PET/CT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).
Time frame
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 PET/CT.
Time frame
24-72 hours post-injection2
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 up3
Number of participants with treatment-related adverse events as assessed by body temperature changes
To assess the safety profile of \[¹⁸F\]FAPI-74 PET/CT.
Time frame
24-72 hours post-injection4
Number of participants with treatment-related adverse events as assessed by blood pressure changes
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame
24-72 hours post-injection Source ClinicalTrials.gov