Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Keywords
PDAC, FAP, FAPI, PET, Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor
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 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.
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 pancreatic ductal adenocarcinoma.
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 PDAC, undergoing staging evaluation for treatment planning. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2: * 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. * 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 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. * Previous cancer diagnosis (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 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 or ulcerative colitis) * Sarcoidosis * Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference | Time Frame: From enrollment to the end of treatment after 3 month follow up | 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). |
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 PET/CT. |
| 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 PET/CT. |
| 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 | 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 Co.
Outcome results
None listed