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Completed

NCT Number: NCT04762719

PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Gastroparesis With Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

PET/CT Scan with 11C-ER176

Drug

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 muscle

Diagnostic Test

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.

Primary outcomes

  1. Uptake of 11C-ER 176 in the Stomach Muscle

    Time frame: 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 outcomes

  1. Percentage of Immune Cells With CD45 Expression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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