PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

NCT04762719 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-010260
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Gastroparesis With Diabetes Mellitus

Keywords

macrophages, immune cells, gastric emptying, gastroparesis, imaging

Outcome Measures

Primary Outcomes (1)

• Uptake of 11C-ER 176 in the Stomach Muscle

  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)

  baseline

Secondary Outcomes (1)

• Percentage of Immune Cells With CD45 Expression

  baseline

Study Arms (3)

Diabetic Gastroparesis Subjects

EXPERIMENTAL

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

Drug: PET/CT Scan with 11C-ER176; Diagnostic Test: Core biopsy of gastric muscle

Diabetic without gastroparesis subjects

EXPERIMENTAL

Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176

Drug: PET/CT Scan with 11C-ER176

Healthy Subjects

PLACEBO COMPARATOR

Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176

Drug: PET/CT Scan with 11C-ER176

Interventions

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.

Diabetic Gastroparesis Subjects; Diabetic without gastroparesis subjects; Healthy Subjects

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.

Diabetic Gastroparesis Subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Madhusudan (Madhu) Grover, M.B.B.S.
• Organization: Mayo Clinic

Grover.Madhusudan@mayo.edu

507-293-2698

Study Officials

• Madhusudan Grover, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three groups of patients (diabetic; diabetic gastroparesis; healthy volunteers) will undergo PET-CT. The diabetic gastroparesis group will also undergo gastric muscle biopsy of the involved and uninvolved area to validate immune changes visualized on imaging.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: May 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-04

Locations

US (1)