PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

March 31, 2022

Study Completion Date

March 31, 2022

Conditions
DiabetesGastroparesis With Diabetes Mellitus
Interventions
DRUG

PET/CT Scan with 11C-ER176

Subjects will have a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh for attenuation correction (CTAC) and anatomic co-localization. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 will be administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh will then be acquired.

DIAGNOSTIC_TEST

Core biopsy of gastric muscle

The echoendoscope (Aloka Arietta 850; Olympus, Center Valley, PA) will be advanced into the gastric lumen and a site targeted for EUS-guided core biopsies based on findings of the PET scan. Fine needle biopsy of the gastric wall will be performed.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER