RecruitingPhase 1NCT05172310

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

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

Sponsor

Karolinska University Hospital

Enrollment

410 participants

Start Date

Jun 2, 2021

Study Type

INTERVENTIONAL

Conditions

Stomach Neoplasms Pancreatic Neoplasms Epithelial Ovarian Cancer Bile Duct Neoplasms

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).

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET scan tracer called 68Ga-FAPI to see if it can better detect and map cancer — specifically pancreatic, bile duct, gastric, and ovarian cancers — compared to existing imaging methods. The tracer targets a protein found in the tissue around tumors. **You may be eligible if...** - You are 18 years of age or older - You are scheduled for surgery to remove a pancreatic, biliary (bile duct), gastric, or ovarian lesion - OR you are having primary or repeat surgery for ovarian cancer, or a biopsy of recurrent ovarian cancer - You are able to provide signed informed consent **You may NOT be eligible if...** - You are under 18 years of age - You are pregnant or breastfeeding - You have significantly reduced kidney function - You have a known allergy to iodinated contrast dye - You have cognitive impairment affecting your ability to make decisions - Your cancer has already spread to other parts of the body (for pancreatic/biliary/gastric groups) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG68Ga-FAPI-46

* \[68Ga\] Ga-FAPI-46 Solution for Injection is manufactured at the Karolinska University Hospital Radiopharmacy facilities, for imaging studies with Positron Emission Tomography (PET). * It is a radiolabelled Fibroblast Activation Protein Inhibitor (FAPI) used for PET of a number of different cancer entities. * Depending on the labelling yield 50 - 370 megabecquerel (MBq) of \[68Ga\] Ga-FAPI-46 Solution for Injection will be administered intravenously 60 minutes prior to whole-body PET image acquisition.

DEVICEPET/CT

* Combined PET and computed tomography (CT) imaging with 68Ga-FAPI-46 will be performed using the same protocol on a "Biograph 6" PET/CT scanner (Siemens, Erlangen, Germany) and "General Electrics" (GE) Discovery 710, Milwaukee, Wisconsin, USA at the Department of Nuclear Medicine, Karolinska Huddinge within 2 weeks before surgery. * PET/CT imaging will be performed in dynamic mode at one bed position centered over the primary tumor for 45 minutes. * At 60 minutes post injection, a whole-body PET will be acquired.