Barrett's EsophagusPhase 2NCT02018367
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
A Phase 2 study testing Proflavine, high resolution imaging in people with Barrett's Esophagus, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
Trial summary
The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Proflavine, high resolution imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.
Who cannot join
- Allergy or prior reaction to the fluorescent contrast agent proflavine
- Patients who are unable to give informed consent.
- Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR
- Patients with a history of a severe allergic reaction (anaphylaxis)
- Patients unable to undergo routine endoscopy with biopsy :
- Women who are pregnant or breastfeeding
Show all 11Show fewer
- Prothrombin Time > 50% of control; PTT > 50 sec, or INR > 2.0)
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
- Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
- Patients with known severe esophagitis
- Patients with suspected but no biopsy confirmed BE
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Madeleine Allman, MPH, 713-798-7585, madeleine.allman@bcm.edu
About this study
Official title: Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).
Read the detailed description
Primary outcomes:
- the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
- compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
- the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
- does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR)
- the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?
Secondary outcomes:
- sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard)
- the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (< 3 cm and > 3cm)
- Conditions
- Barrett's Esophagus
- Being tested
- Proflavine, high resolution imaging
- Keywords
- Barrett's esophagus, proflavine, Microscopic imaging
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proflavine, high resolution imagingDrug
Also called Proflavine hemisulfate
5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Proflavine, high resolution imaging | Experimental | Proflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. Receives: Drug: Proflavine, high resolution imaging |
| Standard of care | No intervention | Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
Measured: 1 day
Secondary outcomes (1)
The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.
To be determined using histopathologic diagnosis of mucosal biopsise as the reference 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 posted23 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Sharmila Anandasabapathy, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018367
- Sponsor's protocol ID
- GCO #12-0289, H-36538
- Status last verified
- Jan 2021
- First submitted
- 9 Dec 2013
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.
PubMed 26253018
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02018367
- Acronym / sponsor ID
- GCO #12-0289, H-36538
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's esophagus, proflavine, Microscopic imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University, Baylor College of Medicine
- Study start
- Sep 2012
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- 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.
The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).
Detailed description
Primary outcomes:
- the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
- compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
- the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
- does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR)
- the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?
Secondary outcomes:
- sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard)
- the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (< 3 cm and > 3cm)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proflavine, high resolution imaging | Experimental | Drug: Proflavine, high resolution imagingProflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. |
| Standard of care | No intervention | –Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.
Key exclusion criteria (11 listed)
- Allergy or prior reaction to the fluorescent contrast agent proflavine
- Patients who are unable to give informed consent.
- Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR
- Patients with a history of a severe allergic reaction (anaphylaxis)
- Patients unable to undergo routine endoscopy with biopsy :
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 |
|---|---|---|
| Proflavine, high resolution imagingAlso: Proflavine hemisulfate5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy. | Drug | Proflavine, high resolution imaging |
Primary outcome
The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Time frame: 1 day
Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
1 secondary outcome
The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 26253018Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.
Related trials for Barrett's Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
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.
Sharmila Anandasabapathy, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proflavine, high resolution imaging in people with Barrett's Esophagus, run by Anandasabapathy, Sharmila, M.D. 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018367, which also lists 1 linked publication.
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 14 Jan 2021.