Suspected or Known Squamous Cell NeoplasiaPhase 2NCT02029937
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
A Phase 2 study testing Proflavine, high resolution imaging in people with Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, run by Anandasabapathy, Sharmila, M.D. at 3 sites in 2 countries.
Trial summary
The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- What is being tested?
- Proflavine, high resolution imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2014to 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
- All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.
Who cannot join
- Allergy or prior reaction to the fluorescent contrast agent proflavine
- Patients who are unable to give informed consent
- Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
- Patient unable to undergo routine endoscopy with biopsy:
- women who are pregnant or breastfeeding
- prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0
- inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites, 2 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS)
Beijing
Yu Xinying, littlenewyxy@163.com
Guiqi Wang
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Fan Zhang, fanzhangchina@163.com
Hong Xu
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Sharmila Anandasabapathy, MD
About this study
Official title: High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact
The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides >1000X magnified images of the esophageal mucosa.
Read the detailed description
Our central hypothesis is that HRME can improve the efficiency and clinical impact of endoscopic screening and surveillance of esophageal squamous cell neoplasia by providing in-vivo optical biopsies comparable to standard histology. Specifically, HRME will allow more detailed evaluation of Lugol's abnormal areas, allowing selective biopsy or removal of neoplastic mucosa. We hypothesize that this will improve the accuracy and diagnostic yield of mucosal sampling.
We also hypothesize the HRME will provide additional, more accurate information regarding the presence of neoplasia that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic therapy (endoscopic mucosal resection or ablation). This could potentially minimize the number of unnecessary biopsies and enable the physician to perform endoscopic therapy at the time of the initial examination, rather than delaying endoscopic treatment to another procedure following pathologic confirmation of the initial biopsies.
Primary Aims:
- To compare the efficiency of HRME + Lugol's chromoendoscopy (HRME + LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. Efficiency will be defined as:
- Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies.
- 'Patients saved': # patients who receive no biopsies
- Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
- To prospectively determine the potential clinical impact of HRME + Lugol's chromoendoscopy (HRME-LC) to Lugol's Chromoendoscopy (LC) by determining if HRME changes the decision to perform endoscopic therapy (endoscopic mucosal resection or ablation) or perform a mucosal biopsy.
- To prospectively compare the performance characteristics of HRME-LC to LC for the prediction of squamous esophageal neoplasia in flat mucosa and mucosal lesions using histopathology as the gold standard: (a) To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per patient analysis
- To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the US and China.
- Conditions
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- Being tested
- Proflavine, high resolution imaging
- Keywords
- Squamous cell neoplasia, Proflavine, Lugol's chromoendoscopy
- Medical subject headings
- Neoplasms
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
5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Proflavine, high resolution imaging | Experimental | 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed. Receives: Drug: Proflavine, high resolution imaging |
| Standard of care | No intervention | No invention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
Efficiency
- Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
- 'Patient saved': # of patients who received no biopsies
- Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
Measured: 1 day
Secondary outcomes (1)
Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
Clinical Impact
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 posted8 Jan 2014 (estimated)
- Study startJan 2014
- 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 Suspected or Known Squamous Cell NeoplasiaStudies 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
- 1,300 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
- NCT02029937
- Sponsor's protocol ID
- GCO 13-0396
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2013
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan MC, Li Z, Patel KK, Zhang F, Yu X, Wang X, Rosen DG, Dawsey SM, Xue L, Hur C, Schwarz RA, Vohra I, Tang Y, Wu M, Wang T, Carns J, Xu H, Richards-Kortum RR, Wang G, Anandasabapathy S. A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial. Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29.
PubMed 39477026
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
- High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact
- ClinicalTrials.gov ID
- NCT02029937
- Acronym / sponsor ID
- GCO 13-0396
- Conditions
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- Keywords
- Squamous cell neoplasia, Proflavine, Lugol's chromoendoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University, Baylor College of Medicine
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jan 2014 (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 multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides >1000X magnified images of the esophageal mucosa.
Detailed description
Our central hypothesis is that HRME can improve the efficiency and clinical impact of endoscopic screening and surveillance of esophageal squamous cell neoplasia by providing in-vivo optical biopsies comparable to standard histology. Specifically, HRME will allow more detailed evaluation of Lugol's abnormal areas, allowing selective biopsy or removal of neoplastic mucosa. We hypothesize that this will improve the accuracy and diagnostic yield of mucosal sampling.
We also hypothesize the HRME will provide additional, more accurate information regarding the presence of neoplasia that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic therapy (endoscopic mucosal resection or ablation). This could potentially minimize the number of unnecessary biopsies and enable the physician to perform endoscopic therapy at the time of the initial examination, rather than delaying endoscopic treatment to another procedure following pathologic confirmation of the initial biopsies.
Primary Aims:
- To compare the efficiency of HRME + Lugol's chromoendoscopy (HRME + LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. Efficiency will be defined as:
- Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies.
- 'Patients saved': # patients who receive no biopsies
- Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
- To prospectively determine the potential clinical impact of HRME + Lugol's chromoendoscopy (HRME-LC) to Lugol's Chromoendoscopy (LC) by determining if HRME changes the decision to perform endoscopic therapy (endoscopic mucosal resection or ablation) or perform a mucosal biopsy.
- To prospectively compare the performance characteristics of HRME-LC to LC for the prediction of squamous esophageal neoplasia in flat mucosa and mucosal lesions using histopathology as the gold standard: (a) To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per patient analysis
- To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the US and China.
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 imaging5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed. |
| Standard of care | No intervention | –No invention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.
Key exclusion criteria (7 listed)
- Allergy or prior reaction to the fluorescent contrast agent proflavine
- Patients who are unable to give informed consent
- Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
- Patient unable to undergo routine endoscopy with biopsy:
- women who are pregnant or breastfeeding
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 hemisulfate5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed. | Drug | Proflavine, high resolution imaging |
Primary outcome
Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
Time frame: 1 day
Efficiency 1. Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies. 2. 'Patient saved': # of patients who received no biopsies 3. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
1 secondary outcome
Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
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 39477026Tan MC, Li Z, Patel KK, Zhang F, Yu X, Wang X, Rosen DG, Dawsey SM, Xue L, Hur C, Schwarz RA, Vohra I, Tang Y, Wu M, Wang T, Carns J, Xu H, Richards-Kortum RR, Wang G, Anandasabapathy S. A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial. Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29.
Related trials for Suspected or Known Squamous Cell Neoplasia
RecruitingPhase 2
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
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
3 sites in 2 countries: 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 Suspected or Known Squamous Cell Neoplasia and Prior History of Squamous Cell Dysplasia and /or Neoplasia, run by Anandasabapathy, Sharmila, M.D. at 3 sites in 2 countries.
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 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: 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 3 sites in China, 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?
Contact Madeleine Allman, MPH (713-798-7585, allman@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. (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 NCT02029937, 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.