Eosinophilic EsophagitisEoENCT03446118
MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients
A study testing MRI to detect inflammation and fibrosis in subjects with EoE in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with Eosinophilic Esophagitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- MRI to detect inflammation and fibrosis in subjects with EoE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18-70 years of age
- Diagnosis of EoE, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy.
- All Subjects diagnosed with Eosinophilic Esophagitis pre and pose therapy
Who cannot join
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy or esophagram (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Pregnant women
- Presence of body metallic fragments or devices that prohibit use of MRI
- History of renal disease
- eGRF <30
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with Eosinophilic Esophagitis
Read the detailed description
MRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy. The following sequences and rationale will be used for the examination:
A sagittal 50mm thick multiphase FIESTA and multiphase SSFSE will be performed while the patient drinks water. The temporal resolution of the images will be approximately 1 image every 1.5-2 seconds. The images will be used to assess the lumen caliber and the wall thickness during maximal distension as pseudothickening can occur with decreased luminal distension.
Sagittal SSFSE with fat suppression, sagittal FRFSE T2-weighted images with fat suppression, axial DWI and sagittal DWI will be performed to asses for edema and inflammation within the esophageal wall.
axial FS SSFSE or FIESTA will be performed and targeted to the region of stricturing.
Dynamic sagittal imaging will be performed following IV contrast to assess for mural hyperenhancement which can be seen mural inflammation and delayed enhancement which can be seen in fibrosis. Sequential acquisitions will be performed beginning at 40 seconds following IV contrast injection. Delayed acquisitions will be performed at 5 min and 7 min. Patients will be asked to perform swallowing during the image acquisition to reduce the potential for pseudoenhancement secondary to under distension.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- MRI to detect inflammation and fibrosis in subjects with EoE
- Keywords
- EoE
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI to detect inflammation and fibrosis in subjects with EoEDiagnostic test
MRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| MRI to detect inflammation and fibrosis in EoE patients | Experimental | To assess through MRI the existence of an inflammatory and fibrotic component in strictures of eosinophilic esophagitis patients and to determine if this component is responsive to a therapeutic course of budesonide. Receives: Diagnostic Test: MRI to detect inflammation and fibrosis in subjects with EoE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
At 5,15 and 25 cm above the gastroesophageal junction and in areas of obvious esophageal thickness, digitized areas of inflammation and fibrosis will be measured individually and as a proportion of overall esophageal diameter in that area before and after steroid treatment.
Measured: 1 day
Secondary outcomes (2)
Barium Esophagram
The barium esophagram will measure moderate stricture formation to delineate the groups- Group 1.(narrowed segment <8 cm in length and lumen diameter > 12mm) and Group 2- 10 will have small caliber esophagus (a narrowed segment >8 cm in length with minimum diameter < 10mm).
Measured: 1 day
Eosinophilic Esophagitis Activity Index (EEsAI)
Questionnaire developed to measure dysphagia - using the pro scoring method
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Mar 2017
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Why it stopped: Terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Twenty patients with eosinophilic esophagitis will be studied. Ten of these patients will have mild to moderate stricture formation (narrowed segment \<8 cm in length and lumen diameter \> 12mm) and 10 will have small caliber esophagus (a narrowed segment \>8 cm in length with minimum diameter \< 10mm). These groups will be delineated by routine barium esophagography performed in all Mayo patients with eosinophilic esophagitis during their initial clinical evaluation. Patients will then undergo an 8 week treatment with 3 mg budesonide twice daily as per routine clinical treatment with clinically indicated follow up endoscopy with esophageal biopsies to assess mucosal response. All patients will complete the EESAI dysphagia score per routine practice at Mayo. MRI of the esophagus will be performed in these patients initially and upon completion of the 8 week course of steroid therapy.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Fidler, Mayo Clinic
- Investigators
- Jeff Fidler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446118
- Sponsor's protocol ID
- 17-006566
- Acronym
- EoE
- Status last verified
- Feb 2022
- First submitted
- 27 Dec 2017
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
- ClinicalTrials.gov ID
- NCT03446118
- Acronym / sponsor ID
- EoE / 17-006566
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EoE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with Eosinophilic Esophagitis
Detailed description
MRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy. The following sequences and rationale will be used for the examination:
A sagittal 50mm thick multiphase FIESTA and multiphase SSFSE will be performed while the patient drinks water. The temporal resolution of the images will be approximately 1 image every 1.5-2 seconds. The images will be used to assess the lumen caliber and the wall thickness during maximal distension as pseudothickening can occur with decreased luminal distension.
Sagittal SSFSE with fat suppression, sagittal FRFSE T2-weighted images with fat suppression, axial DWI and sagittal DWI will be performed to asses for edema and inflammation within the esophageal wall.
axial FS SSFSE or FIESTA will be performed and targeted to the region of stricturing.
Dynamic sagittal imaging will be performed following IV contrast to assess for mural hyperenhancement which can be seen mural inflammation and delayed enhancement which can be seen in fibrosis. Sequential acquisitions will be performed beginning at 40 seconds following IV contrast injection. Delayed acquisitions will be performed at 5 min and 7 min. Patients will be asked to perform swallowing during the image acquisition to reduce the potential for pseudoenhancement secondary to under distension.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Twenty patients with eosinophilic esophagitis will be studied. Ten of these patients will have mild to moderate stricture formation (narrowed segment <8 cm in length and lumen diameter > 12mm) and 10 will have small caliber esophagus (a narrowed segment >8 cm in length with minimum diameter < 10mm). These groups will be delineated by routine barium esophagography performed in all Mayo patients with eosinophilic esophagitis during their initial clinical evaluation. Patients will then undergo an 8 week treatment with 3 mg budesonide twice daily as per routine clinical treatment with clinically indicated follow up endoscopy with esophageal biopsies to assess mucosal response. All patients will complete the EESAI dysphagia score per routine practice at Mayo. MRI of the esophagus will be performed in these patients initially and upon completion of the 8 week course of steroid therapy.
| Arm | Type | Receives |
|---|---|---|
| MRI to detect inflammation and fibrosis in EoE patients | Experimental | Diagnostic Test: MRI to detect inflammation and fibrosis in subjects with EoETo assess through MRI the existence of an inflammatory and fibrotic component in strictures of eosinophilic esophagitis patients and to determine if this component is responsive to a therapeutic course of budesonide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ages 18-70 years of age
- Diagnosis of EoE, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy.
- All Subjects diagnosed with Eosinophilic Esophagitis pre and pose therapy
Key exclusion criteria (8 listed)
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy or esophagram (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- Pregnant women
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 |
|---|---|---|
| MRI to detect inflammation and fibrosis in subjects with EoEMRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy | Diagnostic test | MRI to detect inflammation and fibrosis in EoE patients |
Primary outcome
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
Time frame: 1 day
At 5,15 and 25 cm above the gastroesophageal junction and in areas of obvious esophageal thickness, digitized areas of inflammation and fibrosis will be measured individually and as a proportion of overall esophageal diameter in that area before and after steroid treatment.
2 secondary outcomes
Barium Esophagram
Time frame: 1 day
Eosinophilic Esophagitis Activity Index (EEsAI)
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- 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.
Jeff Fidler, MD 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 study testing MRI to detect inflammation and fibrosis in subjects with EoE in people with Eosinophilic Esophagitis, 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Feb 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to lack of funding). Results are not available in the source record.
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?
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis (time frame: 1 day). 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 28 Feb 2022.