Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 19 and up

Imaging solid tumors using a new tracer called 68Ga-FAPI

Official title: PET Imaging of Tumors in Pancreas, Bile Ducts, Stomach and Ovaries by a Novel Tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor

Run by Karolinska University Hospital · NCT05172310 · Data updated 2026-11-12

This study is testing a new imaging method using a special tracer to see if it can help doctors better detect certain types of cancer in patients who are having surgery.

Quick facts

PhasePhase 1
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment410 (estimated)
SponsorKarolinska University Hospital
Academic / other
Locations1 site (Stockholm)
StatusRecruiting
StartedJune 2, 2021
Main results expectedJune 30, 2024
Study endsMarch 31, 2029
Registry record updatedDecember 29, 2021
Trial IDNCT05172310 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients scheduled for surgical removal of pancreatic, biliary, gastric lesions, or those with early-stage or recurrent epithelial ovarian cancer.

Probably not a fit

Patients with known metastatic disease or those with significantly reduced renal function may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the diagnostic accuracy of PET/CT imaging using a novel radiotracer, 68Ga-FAPI, for detecting cancers of the pancreas, stomach, bile ducts, and epithelial ovarian cancer. The approach focuses on the unique properties of cancer-associated fibroblasts (CAFs) within the tumor stroma, which are abundant in these types of cancers. By selectively targeting the Fibroblast Activation Protein (FAP), the study aims to improve the differentiation of malignant lesions from benign conditions, potentially leading to better treatment decisions. Patients scheduled for surgical removal of these tumors will be enrolled to assess the effectiveness of this imaging technique.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of difficult-to-detect cancers, improving treatment outcomes for patients.

How similar studies have gone: While the use of FAPI in imaging is a novel approach, similar studies have shown promising results in targeting cancer-associated fibroblasts for improved imaging.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Consecutive patients scheduled for surgical removal of either a pancreatic, biliary or gastric lesion.

  \- Consecutive patients scheduled for primary surgical removal of early stage epithelial ovarian cancer (EOC), interval debulking surgery of EOC or surgical removal or tissue biopsy of recurrent EOC
* Signed informed consent.

Common Exclusion Criteria for all study populations:

* Age ≤18 year
* Pregnancy and lactation
* Significantly reduced renal function
* Allergy to iodinated contrast media
* Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment.

Additional Exclusion Criteria for study populations with either pancreatic-, gastric or bile duct cancer:

• Known metastatic disease

Where it's running

  • Karolinska University Hospital Huddinge
    Stockholm, Sweden
    Recruiting

Study contacts

  • Principal investigator: Rimma Axelsson, Professor — Medical Radiation Physics and Nuclear Medicine, Karolinska University Hospital
  • Study coordinator: Rimma Axelsson, Professor
  • Email: rimma.axelsson@ki.se
  • Phone: +46 708 227 622

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.