Suspected or Known Squamous Cell NeoplasiaPhase 2NCT05396781
Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening
A Phase 2 study testing Proflavine and Mobile, Augmented High Resolution Microendoscope 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 2 sites in 2 countries.
Trial summary
The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- 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 and Mobile, Augmented High Resolution Microendoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jan 2022to 20 Jan 2022
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer.
- Patients must be >18 years old and able to give informed consent.
- For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate.
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; Partial Thromboplastin Time greater than 50 sec, or International Normalized Ratio greater than 2.0
- inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
- Providers will be excluded if they decline participation or otherwise opt out of the proposed research project.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening: A Clinical Study in Brazil
The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.
Read the detailed description
The investigators' hypothesis is that this mobile device with automated, AR optical biopsy diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to middle income countries (LMICs) with less experienced providers and is acceptable to providers and patients.
Objective 1: The investigators' first objective is to evaluate the marHRME technology in terms of performance, efficiency, and impact. In a single-arm, feasibility study (n=50) of high-risk subjects undergoing Lugol's chromoendoscopy (LCE) followed by marHRME for esophageal squamous cell neoplasia (ESCN) screening, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' main hypothesis is that the marHRME will:
- increase the accuracy of Lugol's endoscopy (LCE), other exploratory hypotheses are
- increase the accuracy of marHRME among novices and be non-inferior to experts,
- increase user confidence among experts and novices and, subsequently,
- increase the efficiency and impact of LCE by reducing biopsies and second procedures.
For performance for marHRME vs. Standard of Care, the investigators will compare the accuracy of the marHRME + LCE vs. LCE alone to the gold-standard histopathology (expert GI pathologist). For performance of the Machine vs. Man, the investigators will compare accuracy of the marHRME software read to novice and expert clinicians' subjective read to gold-standard histopathology. For clinician confidence and clinical impact, the investigators will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using marHRME.
Objective 2: The investigators' secondary objective is to evaluate the acceptability of the technology among patients and providers. All patients participating in the study will be invited to participate in a brief (20 min) interviewer-administered survey prior to undergoing endoscopy to assess attitudes and barriers to marHRME, and a follow-up interview (7 days post-procedure) to determine experiences and acceptability. Informed consent and the initial interview will be conducted in a private clinic room by trained study staff from the Brazilian team using a brief Portuguese-language survey. The follow-up interview will occur by phone, after a routine follow-up call by clinical staff.
The endoscopists and trainees participating in the feasibility study will be invited to participate in a series of questionnaires and in- depth interviews administered at different time points of the study to assess provider acceptance. Informed consent will be obtained prior to the first interview. Clinicians will answer a brief questionnaire to assess acceptance of marHRME prior to undergoing raining, after training, and after conducting 25 procedures. After 25 procedures, endoscopists and trainees will participate in a 30- minute semi-structured interview to assess marHRME experience. The interviews will be audio recorded, professionally transcribed, and translated (Portuguese to English) for coding and analysis.
- Conditions
- Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
- Being tested
- Proflavine, Mobile, Augmented High Resolution Microendoscope
- 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.
ProflavineDrug
Also called proflavine hemisulfate
5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.
Mobile, Augmented High Resolution MicroendoscopeDevice
Also called marHRME
The marHRME 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 |
|---|---|---|
| Augmented Reality High Resolution Microendoscope (HRME) imaging | Experimental | All study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging. Receives: Drug: Proflavine; Device: Mobile, Augmented High Resolution Microendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
Measured: Day 1
'Patient saved'
The number of patients who received no biopsies.
Measured: Day 1
Procedure time
Total procedure time added by the HRME imaging.
Measured: During Procedure
Secondary outcomes (1)
Clinical impact
The number of cases that a change in clinician plan of action was noted from LCE interpretation only to LCE+HRME interpretation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start13 Jan 2022
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University, Baylor College of Medicine, University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Sharmila Anandasabapathy, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396781
- Sponsor's protocol ID
- H-44015
- Status last verified
- Jun 2022
- First submitted
- 11 Feb 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening: A Clinical Study in Brazil
- ClinicalTrials.gov ID
- NCT05396781
- Acronym / sponsor ID
- H-44015
- 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
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University, Baylor College of Medicine, University of Sao Paulo
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 31 May 2022 (actual)
- 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 investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.
Detailed description
The investigators' hypothesis is that this mobile device with automated, AR optical biopsy diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to middle income countries (LMICs) with less experienced providers and is acceptable to providers and patients.
Objective 1: The investigators' first objective is to evaluate the marHRME technology in terms of performance, efficiency, and impact. In a single-arm, feasibility study (n=50) of high-risk subjects undergoing Lugol's chromoendoscopy (LCE) followed by marHRME for esophageal squamous cell neoplasia (ESCN) screening, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' main hypothesis is that the marHRME will:
- increase the accuracy of Lugol's endoscopy (LCE), other exploratory hypotheses are
- increase the accuracy of marHRME among novices and be non-inferior to experts,
- increase user confidence among experts and novices and, subsequently,
- increase the efficiency and impact of LCE by reducing biopsies and second procedures.
For performance for marHRME vs. Standard of Care, the investigators will compare the accuracy of the marHRME + LCE vs. LCE alone to the gold-standard histopathology (expert GI pathologist). For performance of the Machine vs. Man, the investigators will compare accuracy of the marHRME software read to novice and expert clinicians' subjective read to gold-standard histopathology. For clinician confidence and clinical impact, the investigators will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using marHRME.
Objective 2: The investigators' secondary objective is to evaluate the acceptability of the technology among patients and providers. All patients participating in the study will be invited to participate in a brief (20 min) interviewer-administered survey prior to undergoing endoscopy to assess attitudes and barriers to marHRME, and a follow-up interview (7 days post-procedure) to determine experiences and acceptability. Informed consent and the initial interview will be conducted in a private clinic room by trained study staff from the Brazilian team using a brief Portuguese-language survey. The follow-up interview will occur by phone, after a routine follow-up call by clinical staff.
The endoscopists and trainees participating in the feasibility study will be invited to participate in a series of questionnaires and in- depth interviews administered at different time points of the study to assess provider acceptance. Informed consent will be obtained prior to the first interview. Clinicians will answer a brief questionnaire to assess acceptance of marHRME prior to undergoing raining, after training, and after conducting 25 procedures. After 25 procedures, endoscopists and trainees will participate in a 30- minute semi-structured interview to assess marHRME experience. The interviews will be audio recorded, professionally transcribed, and translated (Portuguese to English) for coding and analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality High Resolution Microendoscope (HRME) imaging | Experimental | Drug: Proflavine, Device: Mobile, Augmented High Resolution MicroendoscopeAll study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer.
- Patients must be >18 years old and able to give informed consent.
- For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate.
Key exclusion criteria (8 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 |
|---|---|---|
| ProflavineAlso: proflavine hemisulfate5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. | Drug | Augmented Reality High Resolution Microendoscope (HRME) imaging |
| Mobile, Augmented High Resolution MicroendoscopeAlso: marHRMEThe marHRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed. | Device | Augmented Reality High Resolution Microendoscope (HRME) imaging |
Primary outcome
Diagnostic yield
Time frame: Day 1
The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
'Patient saved'
Time frame: Day 1
The number of patients who received no biopsies.
Procedure time
Time frame: During Procedure
Total procedure time added by the HRME imaging.
1 secondary outcome
Clinical impact
Time frame: Day 1
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 9 Jun 2022.
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
2 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 and Mobile, Augmented High Resolution Microendoscope 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 2 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 3 inclusion and 8 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. 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?
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?
Diagnostic yield (time frame: Day 1). The study lists 3 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 Jun 2022.