PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI

• Status: Recruiting
• Trial end date: 2029-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Cancers of the pancreas, bile ducts, stomach and ovaries are dismal diseases with most patients being diagnosed in advanced stages leading to a bad prognosis. These cancers can be difficult to diagnose and sometimes impossible to differentiate from underlying benign conditions. Establishing the correct diagnosis of primary cancer lesions and possible spread to other organs in time is pivotal for choosing the right therapy. Routinely applied staging procedures are however not always reliable. The main aim in this study is to evaluate the diagnostic accuracy of PET/CT with a novel radiotracer, FAPI, in the primary diagnosis of cancers in the pancreas, stomach and bile ducts as well as in patients with primary and recurrent epithelial ovarian cancer (EOC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: FAPI-46

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