NCT04762719

PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Dynamic Positron Emission Tomography Imaging With 11C-ER176 to Delineate Macrophage Activation in Diabetic Gastroparesis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage activation in humans. The researchers are trying to determine the utility of 11C-ER176 based PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.

Conditions

• Diabetes
• Gastroparesis With Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-02-21
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study