A Phase 3, Multicenter, Prospective Open-Label Study to Evaluate the Diagnostic Performance of [18F]Fapi-74 Pet/Ct for the Detection of Metastatic Disease in Adults with Pancreatic Ductal Adenocarcinoma

Investigating Imaging Techniques for Detecting Metastatic Disease in Pancreatic Cancer

C
Cindy Yuan

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Ductal Adenocarcinoma, PDAC, Cancer
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the use of a special imaging test called [¹⁸F]FAPI-74 PET/CT to find cancer that has spread in people with a type of pancreatic cancer known as pancreatic ductal adenocarcinoma. Pancreatic ductal adenocarcinoma is a disease where cancer cells form in the tissues of the pancreas. The purpose of this study is to see how well this imaging test works in finding cancer that has spread to other parts of the body.

Participants in the study will receive a single dose of the [¹⁸F]FAPI-74 PET/CT scan. This scan is a type of imaging test that helps doctors see inside the body to find cancer. After the scan, participants will be watched for safety for a short time, between 24 to 72 hours. The study will also collect regular care procedures and information for three months after the scan.

  • Who can participate: Adults aged 18 years and older with confirmed pancreatic ductal adenocarcinoma who are undergoing evaluation for treatment planning can participate. Participants must have a certain level of physical ability and agree to use contraception if applicable.
  • Study details: Participants will receive a special imaging test to detect cancer spread. They will be monitored for safety for 24 to 72 hours after the test. Participants are also required to have a CT scan of the chest, abdomen, and pelvis as part of their standard care.
  • Study timelines: The study will last approximately 24 months.
Updated on 20 Jan 2026. Study ID: RADY-SOFIE-FAPI-PRO, 29894
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only