NCT04762719

PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Completed Phase 2, PHASE3 Results posted Last updated 18 April 2023

What this trial tests

Phase 2, PHASE3 trial testing PET/CT Scan with 11C-ER176 in Diabetes in 12 participants. Completed in 31 March 2022.

Timeline

10 May 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	12
Start date	10 May 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• PET/CT Scan with 11C-ER176 — full drug profile →
• Core biopsy of gastric muscle

Conditions studied

• Diabetes — all drugs for Diabetes →
• Gastroparesis With Diabetes Mellitus — all drugs for Gastroparesis With Diabetes Mellitus →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 70, female only, with Diabetes or Gastroparesis With Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Uptake of 11C-ER 176 in the Stomach Muscle Primary · baseline

All patients will have a PET/CT with 11C-ER 176. On each PET image, volumes of interest areas will be drawn around the stomach and other organs that may show radiotracer accumulation. The uptake of radiotracer 11C-ER 176 in each area will be quantified and reported as maximum standardized uptake values (SUVmax)

stomach pylorus

Group	Value	95% CI
Diabetic Gastroparesis Subjects	5.5	± 1.0
Diabetic Without Gastroparesis Subjects	8.4	± 4.1
Healthy Subjects	4.6	± 0.2

stomach gastric fundus

Group	Value	95% CI
Diabetic Gastroparesis Subjects	7.8	± 1.9
Diabetic Without Gastroparesis Subjects	13.1	± 8.3
Healthy Subjects	9.0	± 1.6

stomach body

Group	Value	95% CI
Diabetic Gastroparesis Subjects	7.8	± 1.9
Diabetic Without Gastroparesis Subjects	13.0	± 9.2
Healthy Subjects	7.7	± 1.9

duodenum

Group	Value	95% CI
Diabetic Gastroparesis Subjects	7.0	± 1.8
Diabetic Without Gastroparesis Subjects	9.5	± 6.8
Healthy Subjects	6.2	± 2.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each subject from baseline to end of study, approximately 14 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diabetic Gastroparesis Subjects

Serious: 0/4 (0%)

Deaths: 0/4

Diabetic Without Gastroparesis Subjects

Serious: 0/4 (0%)

Deaths: 0/4

Healthy Subjects

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (3 terms — click to expand)

Reaction	System	Diabetic Gastroparesis Sub…	Diabetic Without Gastropar…	Healthy Subjects
Sore throat	Gastrointestinal disorders	—	—	—
Uvular abrasion	Gastrointestinal disorders	—	—	—
Urinary Tract Infection	Renal and urinary disorders	—	—	—

Data from ClinicalTrials.gov NCT04762719 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
   van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155
2. Synthesis and evaluation of TSPO-targeting radioligand [<sup>18</sup>F]F-TFQC for PET neuroimaging in epileptic rats.
   Fu W, Lin Q, Fu Z, Yang T, et al · · 2025 · cited 2× · PMID 40177559 · DOI 10.1016/j.apsb.2024.05.031