Barrett's EsophagusEarly Phase 1NCT01384864
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
A Early Phase 1 study testing proflavine in people with Barrett's Esophagus and Intraepithelial Neoplasia, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
Trial summary
The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Intraepithelial Neoplasia
- What is being tested?
- proflavine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2015
- 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
- 18 years or older
- known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.
- Conditions
- Barrett's Esophagus, Intraepithelial Neoplasia
- Being tested
- proflavine
- Keywords
- barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination
- Medical subject headings
- Barrett Esophagus, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proflavineDrug
Also called Proflavine hemisulfate
2-6 ml of 0.01% proflavine
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | fluorescent imaging with proflavine Receives: Drug: proflavine |
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 startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384864
- Sponsor's protocol ID
- GCO# 09-0696 Project 3
- Status last verified
- Jan 2016
- First submitted
- 28 Jun 2011
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
- ClinicalTrials.gov ID
- NCT01384864
- Acronym / sponsor ID
- GCO# 09-0696 Project 3
- Conditions
- Barrett's Esophagus, Intraepithelial Neoplasia
- Keywords
- barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (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 pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of 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 |
|---|---|---|
| treatment | Experimental | Drug: proflavinefluorescent imaging with proflavine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| proflavineAlso: Proflavine hemisulfate2-6 ml of 0.01% proflavine | Drug | treatment |
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 11 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Barrett's Esophagus and Intraepithelial Neoplasia, 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 2 inclusion and 1 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 11 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?
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 11 Jan 2016.