Proflavine, high resolution imaging for Precancerous lesions

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

No Placebo-Only Group

All Individual Drugs Already Approved

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

Precancerous lesions
Skin Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy

Other study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 1Eligibility criteria met