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

PHASE1RecruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

June 2, 2021

Primary Completion Date

June 30, 2024

Study Completion Date

March 31, 2029

Conditions
Pancreatic NeoplasmsStomach NeoplasmsBile Duct NeoplasmsEpithelial Ovarian Cancer
Interventions
DRUG

68Ga-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."

DEVICE

PET/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."

Trial Locations (1)

14186

RECRUITING

Karolinska University Hospital Huddinge, Stockholm

All Listed Sponsors
lead

Karolinska University Hospital

OTHER

NCT05172310 - PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI | Biotech Hunter | Biotech Hunter