Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- Registration Number
- NCT07217717
- Lead Sponsor
- SOFIE
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 [18F]FAPI-74 PET/CT -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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