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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Healthy Subjects | Placebo Comparator | Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Immune Cells With CD45 Expression | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Subjects Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Madhusudan Grover, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Gastroparesis Subjects | 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), received a PET/CT scan with 11C-ER176 and a core biopsy of gastric muscle. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. Core biopsy of gastric muscle: The echoendoscope (Aloka Arietta 850; Olympus, Center Valley, PA) was 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 was performed. |
| FG001 | Diabetic Without Gastroparesis Subjects | Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
| FG002 | Healthy Subjects | Healthy subjects were age-matched and received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Gastroparesis Subjects | 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), received a PET/CT scan with 11C-ER176 and a core biopsy of gastric muscle. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. Core biopsy of gastric muscle: The echoendoscope (Aloka Arietta 850; Olympus, Center Valley, PA) was 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 was performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | SUVmax | baseline |
|
Adverse events were collected for each subject from baseline to end of study, approximately 14 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic Gastroparesis Subjects | 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), received a PET/CT scan with 11C-ER176 and a core biopsy of gastric muscle. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. Core biopsy of gastric muscle: The echoendoscope (Aloka Arietta 850; Olympus, Center Valley, PA) was 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 was performed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhusudan (Madhu) Grover, M.B.B.S. | Mayo Clinic | 507-293-2698 | Grover.Madhusudan@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2021 | Apr 14, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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|
| 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. |
|
| baseline |
| BG001 | Diabetic Without Gastroparesis Subjects | Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
| BG002 | Healthy Subjects | Healthy subjects were age-matched and received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Diabetic Without Gastroparesis Subjects | Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
| OG002 | Healthy Subjects | Healthy subjects were age-matched and received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. |
|
|
| Secondary | Percentage of Immune Cells With CD45 Expression | 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. | The tissue obtained from diabetic gastroparesis group was not of sufficient size or volume to perform quantitative (%) assessment. Outcome measure for diabetic gastroparesis subjects only. | Posted | baseline |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Diabetic Without Gastroparesis Subjects | Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Healthy Subjects | Healthy subjects were age-matched and received a PET/CT scan with 11C-ER176. PET/CT scan with 11C-ER176: Subjects received a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 was administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh was then acquired. | 0 | 4 | 0 | 4 | 0 | 4 |
| Uvular abrasion | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |