FAPI-PET imaging in solid tumors
Phase 1
Active, not recruiting
- Conditions
- CancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- CTIS2024-514967-25-00
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 410
Inclusion Criteria
1.The subject has given written consent to participate in the study, 2.The subject has suspected pancreatic, gastric, biliary or epithelial ovarian cancer based on multimodal strategy including markers in blood, markers in tissue and imaging diagnostics; scheduled for surgical removal of this lesion with histopathological confirmation of diagnosis.
Exclusion Criteria
Age =18 year, Pregnancy and lactation, Known metastatic disease (Not applicable for the EOC study group as most cases are already metastasized at the point of primary diagnosis), 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve non-invasive diagnostics of malignancy in tumors of pancreas, stomach, and bile ducts, as well as in epithelial ovarian cancer (EOC);Secondary Objective: To evaluate FAPI- PET/CT as a staging tool for pancreatic-, gastric- and bile duct cancers as well as for primary and recurrent EOC, To investigate the correlation between in-vivo uptake of FAPI and ex-vivo immunohistochemically determined biomarker (FAP, PDGFR-a, PDGFR-ß and a-SMA) expression in the stroma of these tumors, To evaluate FAPI- PET/CT and stroma markers as prognostic factors in patients with these cancer entities, To investigate the correlation between FAPI- PET/CT imaging results with those of conventional radiology performed according to clinical routine (SOP), i.e. CT and MRT imaging, as well as gastroscopy including biopsy for the patient group with gastric cancer, To evaluate the safety and tolerability of the investigational product;Primary end point(s): Surgery with histopathological confirmation of diagnosis
- Secondary Outcome Measures
Name Time Method