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

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.

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