Precision Optical Guidance for Oral Biopsy

Last updated: February 13, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Canker Sores

Treatment

Optical Mapping Scope

Proflavine hemisulfate

High Resolution Microendoscope (HRME)

Clinical Study ID

NCT05554133
2020-1115
R01DE029590-01
NCI-2022-07929
  • Ages > 18
  • All Genders

Study Summary

To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult subjects with clinically evident oral lesions such as leukoplakia orerythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus andgraft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma,or a history of resected oral cancer, are eligible to participate. Patients withprevious treatment including surgery, radiation, chemotherapy or other therapies arealso eligible.

  2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Exclusion

Exclusion Criteria:

  1. Known allergy to proflavine or acriflavine.

  2. Age less than 18 years.

  3. Pregnant or nursing females.

  4. Adults unable to consent

  5. Prisoners and other vulnerable populations

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Optical Mapping Scope
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
March 31, 2027

Study Description

Primary objective:

-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.

Secondary objective:

-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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