Malignant Skin Neoplasm, Skin Disorder, Skin Neoplasm
Conditions
Brief summary
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.
Detailed 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.
Interventions
Undergo qOBM
RADIATIONRadiation Therapy
Undergo SOC RT
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| qOBM Clinical Assessment | Up to 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Usability of the qOBM Device | Up to 12 months | 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. |
Countries
United States
Contacts
Primary ContactMohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR
Outcome results
None listed