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Proflavine, high resolution imaging for Squamous Cell Neoplasia

Phase 2
Waitlist Available
Led By Sharmila Anandasabapathy, MD
Research Sponsored by Anandasabapathy, Sharmila, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial will test whether using a high-resolution microendoscope during upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia.

Eligible Conditions
  • Squamous Cell Neoplasia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
Other outcome measures
Comparison of the performance characteristics of HRME to LC for the prediction of squamous esophageal neoplasia using histopatholgy as the gold standard. The cost-effectiveness of HRME-LC to LC alone.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Proflavine, high resolution imagingExperimental Treatment1 Intervention
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.
Group II: Standard of careActive Control1 Intervention
No invention

Find a Location

Who is running the clinical trial?

Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,000,952 Total Patients Enrolled
William Marsh Rice UniversityOTHER
45 Previous Clinical Trials
26,553 Total Patients Enrolled
Anandasabapathy, Sharmila, M.D.Lead Sponsor
7 Previous Clinical Trials
531 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
2014. "High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02029937.
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~116 spots leftby Apr 2025
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