Sponsor study identifier
interventional
12
1 country
1
Study Start
May 10, 2021
Actual (reported)Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2021
Actual (reported)February 21, 2021
Actual (reported)May 10, 2021
Actual (reported)March 31, 2022
Actual (reported)March 31, 2022
Actual (reported)April 18, 2023
Actual (reported)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
Percentage of Immune Cells With CD45 Expression
baseline
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
Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176
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.
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Madhusudan Grover, MBBS
Mayo Clinic
12 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2021
First Posted
February 21, 2021
Study Start
ANDES-AGI-1067 as a Novel Antidiabetic Agent Evaluation Study
Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
May 10, 2021
Actual (reported)Primary Completion
March 31, 2022
Actual (reported)Study Completion
March 31, 2022
Actual (reported)Last Updated
April 18, 2023
Results First Posted
April 18, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: