Precision Optical Guidance for Oral Biopsy

Not Applicable

Recruiting

• Conditions: Oral Lesions
• Interventions: Device: High Resolution Microendoscope (HRME); Device: Optical Mapping Scope; Drug: Proflavine hemisulfate

• Registration Number: NCT05554133
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Study Start: 2023-06-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Active Biopsy Guidance System	Optical Mapping Scope	This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
The Active Biopsy Guidance System	High Resolution Microendoscope (HRME)	This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):
The Active Biopsy Guidance System	Proflavine hemisulfate	This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

Primary Outcome Measures

Name	Time	Method
To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology	Through study completion an average of 1 year.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States