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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Quantitative Oblique Back-Illumination Microscopy

    Procedure/Surgery

    Undergo qOBM

  • Radiation Therapy

    Radiation

    Undergo SOC RT

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Group I (qOBM)Experimental treatment 1 intervention
Group B: Group II (qOBM, SOC RT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 12 months

Secondary outcomes

1

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.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator