CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
PET/CT Scan with 11C-ER176 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04762719
NCT04762719Phase 3Completed
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Dynamic Positron Emission Tomography Imaging With 11C-ER176 to Delineate Macrophage Activation in Diabetic Gastroparesis

Mayo Clinic·interventional·Posted Feb 21, 2021·Updated Apr 18, 2023

In Brief

A Phase 3 clinical trial evaluating PET/CT Scan with 11C-ER176 and Core biopsy of gastric muscle for Diabetes and Gastroparesis With Diabetes Mellitus. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Gastroparesis With Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartMay 10, 2021
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago

Interventions

PET/CT Scan with 11C-ER176drug

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.

Core biopsy of gastric muscleother

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.