PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Phase 2

Completed

• Conditions: Gastroparesis With Diabetes Mellitus; Diabetes
• Interventions: Drug: PET/CT Scan with 11C-ER176; Diagnostic Test: Core biopsy of gastric muscle

• Registration Number: NCT04762719
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-05-10
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Results First Submitted: 2023-03-22
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Age: 18 to 70 years of age.
• Ability to provide informed consent.
• Type I or II diabetes mellitus.
• Gastroparesis defined by gastric retention of Tc-99m > 60 % at 2 hrs and/or > 10% at 4 hours on scintigraphy.
• Average Gastroparesis Cardinal Symptom Index (GCSI) ≥ 3 indicating moderate-severe symptoms.

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Exclusion Criteria

• Women who are pregnant or cannot stop breast feeding for 24 hours.
• Using anti-coagulants, anti-inflammatory medications (NSAIDs, corticosteroids, etc.) or immunosuppressive therapies within the 4 weeks prior.
• Opioid use within the last 4 weeks of gastric emptying scintigraphy.
• Prior gastric surgery.
• History of IBD, celiac disease, eosinophilic gastroenteritis, microscopic colitis.

Healthy Subjects Exclusion criteria

• no clinical history of diabetes or any GI symptoms
• no inflammatory disorders of the GI tract
• no use of anti-inflammatory or immunosuppressive therapies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic Gastroparesis Subjects	Core biopsy of gastric muscle	Type I or II diabetes subjects who also have a diagnosis of Gastroparesis (defined by gastric retention of Tc-99m \>20% at 4 hrs on scintigraphy). Subjects will receive PET/CT Scan with 11C-ER176 and a core biopsy of gastric muscle
Diabetic Gastroparesis Subjects	PET/CT Scan with 11C-ER176	Type I or II diabetes subjects who also have a diagnosis of Gastroparesis (defined by gastric retention of Tc-99m \>20% at 4 hrs on scintigraphy). Subjects will receive PET/CT Scan with 11C-ER176 and a core biopsy of gastric muscle
Healthy Subjects	PET/CT Scan with 11C-ER176	Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176
Diabetic without gastroparesis subjects	PET/CT Scan with 11C-ER176	Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176

Primary Outcome Measures

Name	Time	Method
Uptake of 11C-ER 176 in the Stomach Muscle	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)

Secondary Outcome Measures

Name	Time	Method
Percentage of Immune Cells With CD45 Expression	baseline	An upper endoscopy procedure was done for diabetic gastroparesis patients and full thickness core tissue samples were taken in the stomach in areas that demonstrated 11C-ER 176 uptake in the PET scan as well as non-enhancing control areas. Cytometry by time of flight (CyTOF) mass spectrometry system was used to determine the proportions of immune cell types with CD45.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States