Imaging solid tumors using a new tracer called 68Ga-FAPI
PET Imaging of Tumors in Pancreas, Bile Ducts, Stomach and Ovaries by a Novel Tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05172310 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with known metastatic disease or those with significantly reduced renal function may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stockholm
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.