Barrett's EsophagusEarly Phase 1NCT01384227
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
A Early Phase 1 study testing Proflavine Hemisulfate in people with Barrett's Esophagus, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
Trial summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. 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 Hemisulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Early Phase 1
- 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
- Barrett's without dysplasia
- Barrett's with dysplasia
- Esophageal Adenocarcinoma
Who cannot join
- Subjects unfit for standard upper endoscopy
- Subjects currently receiving chemo or radiation treatment
- Subject currently receiving PDT or ablation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.
- Conditions
- Barrett's Esophagus
- Being tested
- Proflavine Hemisulfate
- Keywords
- Barrett's esophagus, in vivo imaging, image guide microscope
- 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 HemisulfateDrug
Also called Proflavine
Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
| Study group | Role | What they receive |
|---|---|---|
| Proflavine Hemisulfate | Experimental | Not described Receives: Drug: Proflavine Hemisulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether tissue is neoplastic or non-neoplastic
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 posted29 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
- Investigators
- Sharmila Anandasabapathy, Principal investigator, Mt. Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384227
- Sponsor's protocol ID
- GCO # 08-1190
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2011
- Last updated
- 12 Jan 2016
- 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 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01384227
- Acronym / sponsor ID
- GCO # 08-1190
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's esophagus, in vivo imaging, image guide microscope
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 29 Jun 2011 (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 objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proflavine Hemisulfate | Experimental | Drug: Proflavine Hemisulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Barrett's without dysplasia
- Barrett's with dysplasia
- Esophageal Adenocarcinoma
Key exclusion criteria (3 listed)
- Subjects unfit for standard upper endoscopy
- Subjects currently receiving chemo or radiation treatment
- Subject currently receiving PDT or ablation
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 HemisulfateAlso: ProflavineProflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water) | Drug | Proflavine Hemisulfate |
Primary outcome
To determine whether tissue is neoplastic or non-neoplastic
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- 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
"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
Active, not recruitingObservational study
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus, Barretts Esophagus With Dysplasia
Active, not recruiting
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus
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 principal investigator
Mt. Sinai School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Proflavine Hemisulfate 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 3 inclusion and 3 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 12 Jan 2016. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine whether tissue is neoplastic or non-neoplastic (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 NCT01384227, 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 12 Jan 2016.