Esophageal CancerNCT03385343
Staging of Superficial EAC Using VLE
A study testing VLE imaging for staging EAC in people with Esophageal Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- VLE imaging for staging EAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 8 Sep 2021
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18
- Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade <B, C, and D)
Who cannot join
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anticoagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
Read the detailed description
Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect dysplasia associated with Barrett's esophagus (BE) but its use in cancer staging has not been previously explored. The investigators propose that VLE can accurately and comprehensively stage T1 EAC.
VLE scans will be analyzed using an automated computer algorithm to measure degree of signal attenuation over areas demarcated for endoscopic mucosal resection (EMR). The signal attenuation cut-off established will be used to classify cancers as superficial versus deep. EMR specimens will be reviewed histopathologically for grade of tumor differentiation, depth of invasion, and presence or absence of lymphovascular invasion. Depth of tumor invasion will be measured and used to classify cancers as superficial versus deep.
- Conditions
- Esophageal Cancer
- Being tested
- VLE imaging for staging EAC
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLE imaging for staging EACDiagnostic test
Also called NvisionVLE Imaging System
Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)
| Study group | Role | What they receive |
|---|---|---|
| VLE imaging of stage EAC | Experimental | All subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. Receives: Diagnostic Test: VLE imaging for staging EAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.
Measured: 1 day
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC
To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.
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 posted28 Dec 2017
- Study start5 May 2017
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Why it stopped: Device company went out of business
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 Esophageal CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cadman Leggett, Mayo Clinic
- Investigators
- Cadman L Leggett, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385343
- Sponsor's protocol ID
- 17-002723
- Status last verified
- Apr 2023
- First submitted
- 29 Aug 2017
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
- ClinicalTrials.gov ID
- NCT03385343
- Acronym / sponsor ID
- 17-002723
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device company went out of business
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
Detailed description
Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect dysplasia associated with Barrett's esophagus (BE) but its use in cancer staging has not been previously explored. The investigators propose that VLE can accurately and comprehensively stage T1 EAC.
VLE scans will be analyzed using an automated computer algorithm to measure degree of signal attenuation over areas demarcated for endoscopic mucosal resection (EMR). The signal attenuation cut-off established will be used to classify cancers as superficial versus deep. EMR specimens will be reviewed histopathologically for grade of tumor differentiation, depth of invasion, and presence or absence of lymphovascular invasion. Depth of tumor invasion will be measured and used to classify cancers as superficial versus deep.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLE imaging of stage EAC | Experimental | Diagnostic Test: VLE imaging for staging EACAll subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over the age of 18
- Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade <B, C, and D)
Key exclusion criteria (7 listed)
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
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 |
|---|---|---|
| VLE imaging for staging EACAlso: NvisionVLE Imaging SystemVolumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC) | Diagnostic test | VLE imaging of stage EAC |
Primary outcome
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
Time frame: 1 day
A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC
Time frame: 1 day
To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Cadman L Leggett, M.D. 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 VLE imaging for staging EAC in people with Esophageal Cancer, 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 4 inclusion and 7 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 9 May 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. 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?
Yes. Results are posted in the registry (first posted 9 May 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?
Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion (time frame: 1 day). The study lists 2 primary outcomes in all. 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 9 May 2023.