Trial Outcomes & Findings for PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis (NCT NCT04762719)

Last Updated: 2023-04-18

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

12 participants

Primary outcome timeframe

baseline

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	4	4	4
Overall Study COMPLETED	4	4	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic Gastroparesis Subjects n=4 Participants 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.	Diabetic Without Gastroparesis Subjects n=4 Participants 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.	Healthy Subjects n=4 Participants 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.	Total n=12 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 7.0 • n=5 Participants	48.0 years STANDARD_DEVIATION 13.0 • n=7 Participants	47.0 years STANDARD_DEVIATION 11.0 • n=5 Participants	48.0 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Diabetic Gastroparesis Subjects n=4 Participants 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.	Diabetic Without Gastroparesis Subjects n=4 Participants 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.	Healthy Subjects n=4 Participants 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.
Uptake of 11C-ER 176 in the Stomach Muscle stomach pylorus	5.5 SUVmax Standard Deviation 1.0	8.4 SUVmax Standard Deviation 4.1	4.6 SUVmax Standard Deviation 0.2
Uptake of 11C-ER 176 in the Stomach Muscle stomach gastric fundus	7.8 SUVmax Standard Deviation 1.9	13.1 SUVmax Standard Deviation 8.3	9.0 SUVmax Standard Deviation 1.6
Uptake of 11C-ER 176 in the Stomach Muscle stomach body	7.8 SUVmax Standard Deviation 1.9	13.0 SUVmax Standard Deviation 9.2	7.7 SUVmax Standard Deviation 1.9
Uptake of 11C-ER 176 in the Stomach Muscle duodenum	7.0 SUVmax Standard Deviation 1.8	9.5 SUVmax Standard Deviation 6.8	6.2 SUVmax Standard Deviation 2.1

SECONDARY outcome

Timeframe: baseline

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Diabetic Gastroparesis Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Diabetic Without Gastroparesis Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diabetic Gastroparesis Subjects n=4 participants at risk 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.	Diabetic Without Gastroparesis Subjects n=4 participants at risk 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.	Healthy Subjects n=4 participants at risk 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.
Gastrointestinal disorders Sore throat	25.0% 1/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.
Gastrointestinal disorders Uvular abrasion	25.0% 1/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.
Renal and urinary disorders Urinary Tract Infection	25.0% 1/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.	0.00% 0/4 • Adverse events were collected for each subject from baseline to end of study, approximately 14 days.

Additional Information

Madhusudan (Madhu) Grover, M.B.B.S.

Mayo Clinic

Phone: 507-293-2698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place