Optical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions

Emory University

Status: Not yet enrolling

Conditions: Skin Disorder; Skin Neoplasm; Malignant Skin Neoplasm

Treatments: Procedure: Quantitative Oblique Back-Illumination Microscopy; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07213154

P30CA138292 (U.S. NIH Grant/Contract)

WINSHIP6407-24 (Other Identifier)

STUDY00008502 (Other Identifier)

NCI-2025-02356 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies how well an optical imaging scan called quantitative oblique back-illumination microscopy (qOBM) helps in diagnosing skin cancer in patients with skin lesions. qOBM is a non-invasive procedure that uses red light for illumination, and may work better than no imaging procedures in aiding doctors in diagnosing skin lesions.

Full description

PRIMARY OBJECTIVE:

I. To perform a first-in-human study to assess the ability of a qOBM handheld device to reliably image skin pathology in-situ and in-vivo.

SECONDARY OBJECTIVES:

I. Characterize a wide variety of lesions including but limited to:

Ia. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc,; Ib. Non-malignant lesions: keloids, surgical scars, actinic keratosis, benign and dysplastic nevi, cysts, lipoma; Ic. Inflammatory conditions: psoriasis, eczema, alopecia, acne, wounds, etc); Id. Characterize pre and post treatment changes in the lesion as well as the surrounding normal tissue stroma (examples, but not limited to: changes to hair follicles, epidermis, dermis, subcutaneous tissue, erector pillae muscles, vessels, nerves, etc); Ie. Correlate optical findings with histological findings for lesions that would have been removed surgically and/or are biopsied (examples, but not limited to: removal of a skin cancer where optical imaging is used to characterize peripheral extent of the lesion as well as depth of penetration, a benign versus malignant lesion, pigmented versus [vs] non-pigmented lesion, etc).

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients who have skin melanoma and/or suspected dysplastic nevi undergo qOBM optical imaging scan on study. Patients may undergo 2 additional qOBM optical imaging scans at the discretion of the treating physician. After qOBM scans, patients who are diagnosed with skin cancer may proceed to Group II.

GROUP II: Patients with skin cancer who are undergoing standard of care (SOC) radiation therapy (RT) undergo qOBM optical imaging scans prior to- and during or after SOC RT on study. Patients may also undergo qOBM optical imaging scans additional at approximately 1, 6, and 12 months after completion of SOC RT at the discretion of the treating physician.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female
• Candidate with skin lesions
• Signed study-specific informed consent prior to study entry
• ≥ 18 years old

Exclusion criteria

• Prior surgery or radiotherapy to the area to be treated

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group I (qOBM)

Experimental group

Description:

Patients who have skin melanoma and/or suspected dysplastic nevi undergo qOBM optical imaging scan on study. Patients may undergo 2 additional qOBM optical imaging scans at the discretion of the treating physician. After qOBM scans, patients who are diagnosed with skin cancer may proceed to Group II.

Treatment:

Procedure: Quantitative Oblique Back-Illumination Microscopy

Group II (qOBM, SOC RT)

Experimental group

Description:

GROUP II: Patients with skin cancer who are undergoing SOC RT undergo qOBM optical imaging scans prior to- and during or after SOC RT on study. Patients may also undergo qOBM optical imaging scans additional at approximately 1, 6, and 12 months after completion of SOC RT at the discretion of the treating physician.

Treatment:

Radiation: Radiation Therapy

Procedure: Quantitative Oblique Back-Illumination Microscopy