DiabetesPhase 2/3NCT04762719
PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis
A Phase 2/3 study testing PET/CT Scan with 11C-ER176 and Core biopsy of gastric muscle in people with Diabetes and Gastroparesis With Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gastroparesis With Diabetes Mellitus
- What is being tested?
- PET/CT Scan with 11C-ER176 and Core biopsy of gastric muscle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 31 Mar 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- no clinical history of diabetes or any GI symptoms
- no inflammatory disorders of the GI tract
- no use of anti-inflammatory or immunosuppressive therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Dynamic Positron Emission Tomography Imaging With 11C-ER176 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.
- Conditions
- Diabetes, Gastroparesis With Diabetes Mellitus
- Being tested
- PET/CT Scan with 11C-ER176, Core biopsy of gastric muscle
- Keywords
- macrophages, immune cells, gastric emptying, gastroparesis, imaging
- Medical subject headings
- Diabetes Mellitus, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT Scan with 11C-ER176Drug
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 muscleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: PET/CT Scan with 11C-ER176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline
Secondary outcomes (1)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 May 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhusudan (Madhu) Grover, MBBS, Mayo Clinic
- Investigators
- Madhusudan Grover, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762719
- Sponsor's protocol ID
- 20-010260
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2021
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Positron Emission Tomography Imaging With 11C-ER176 to Delineate Macrophage Activation in Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT04762719
- Acronym / sponsor ID
- 20-010260
- Conditions
- Diabetes, Gastroparesis With Diabetes Mellitus
- Keywords
- macrophages, immune cells, gastric emptying, gastroparesis, imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diabetic Gastroparesis Subjects | Experimental | Drug: PET/CT Scan with 11C-ER176, Diagnostic Test: Core biopsy of gastric muscleType 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 | Drug: PET/CT Scan with 11C-ER176Type 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 | Drug: PET/CT Scan with 11C-ER176Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT Scan with 11C-ER176Subjects 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. | Drug | Diabetic Gastroparesis Subjects, Diabetic without gastroparesis subjects, Healthy Subjects |
| Core biopsy of gastric muscleThe 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. | Diagnostic test | Diabetic Gastroparesis Subjects |
Primary outcome
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)
1 secondary outcome
Percentage of Immune Cells With CD45 Expression
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhusudan Grover, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PET/CT Scan with 11C-ER176 and Core biopsy of gastric muscle in people with Diabetes and Gastroparesis With Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of 11C-ER 176 in the Stomach Muscle (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.