Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions

What this Trial Is About

Researchers are evaluating a new non-invasive optical imaging technique called quantitative oblique back-illumination microscopy (qOBM) to help diagnose skin cancer in patients who have skin lesions. This method uses red light and may provide better imaging compared to no imaging procedures. The study aims to assess the ability of a handheld qOBM device to reliably image various skin pathologies including malignant and non-malignant lesions, inflammatory conditions, and tissue changes before and after treatment. Participants are assigned to one of two groups based on their condition. Group I includes patients with skin melanoma or suspected dysplastic nevi who will undergo qOBM imaging scans, potentially up to three times. Group II consists of patients with confirmed skin cancer undergoing standard radiation therapy (SOC RT) who receive qOBM scans before, during, and after their radiation treatment. Follow-up qOBM scans may occur about 1, 6, and 12 months after radiation therapy as decided by the physician. During the study, participants undergo multiple qOBM scans to evaluate skin lesions and treatment effects. Researchers will compare optical imaging findings with histological results from biopsies or surgeries when available. The primary outcome measured is the clinical assessment using qOBM over up to 12 months. Usability of the qOBM device will also be evaluated. The study involves ongoing monitoring during and after radiation therapy to understand the imaging technology's performance and potential clinical benefits.

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