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

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).

Interventions

• 68Ga-FAPI-46 · DRUG

  * \[68Ga\] 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.

• PET/CT · DEVICE

  * 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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Karolinska University Hospital Huddinge, Stockholm, Sweden · RECRUITING