About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female
Candidate with skin lesions
Signed study-specific informed consent prior to study entry
≥ 18 years old
Disqualifiers
Prior surgery or radiotherapy to the area to be treated
Trial design
Parallel
Treatments tested in this trial
Quantitative Oblique Back-Illumination Microscopy
Procedure/SurgeryUndergo qOBM
Radiation Therapy
RadiationUndergo SOC RT
Treatment groups
Trial outcomes
Primary outcomes
qOBM Clinical Assessment
Assessing the application of quantitative oblique back-illumination microscopy (qOBM) to assess skin pathology. Analysis will be descriptive in nature (e.g., appearance of cells in the epidermis, dermis, and basal junction). Quantitative analysis will include extracting image features such as mean, standard deviation, and kurtosis of the phase values; entropy, fractal dimension, gray level co-occurrence matrix, and other mathematical image features. Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria (Skin) Grade 0. No change over baseline, Grade 1. Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating, Grade 2. Tender or bright erythema, patchy moist desquamation/moderate edema, Grade 3. Confluent, moist desquamation other than skin folds, pitting edema, Grade 4. Ulceration, hemorrhage, necrosis
Secondary outcomes
Usability of the qOBM Device
Will collect information regarding the usability of the device, including how ergonomic it is, ideal for factors for acquiring images and visualizing structures in real time. Quantitative analysis will include extracting image features such as mean, standard deviation, and kurtosis of the phase values; entropy, fractal dimension, gray level co-occurrence matrix, and other mathematical image features. Differences between similar diagnoses vs adjacent normal skin will be evaluated using a two-sided t-test.
Sponsors and contacts
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator