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

Purpose

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.

Conditions

  • Malignant Skin Neoplasm
  • Skin Disorder
  • Skin Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (qOBM) 		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.
  • Procedure: Quantitative Oblique Back-Illumination Microscopy
    Undergo qOBM
    Other names:
    • qOBM
Experimental
Group II (qOBM, SOC RT) 		GROUP II: Patients with skin cancer who are undergoing SOC 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.
  • Procedure: Quantitative Oblique Back-Illumination Microscopy
    Undergo qOBM
    Other names:
    • qOBM
  • Radiation: Radiation Therapy
    Undergo SOC RT
    Other names:
    • Cancer Radiotherapy
    • Energy Type
    • ENERGY_TYPE
    • Irradiate
    • Irradiated
    • Irradiation
    • Radiation
    • Radiation Therapy, NOS
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation

Recruiting Locations

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
Contact:
Tiffaney Roundtree
tiffaney.laquinta.roundtree@emory.edu

Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Contact:
Tiffaney K. Roundtree
tiffaney.laquinta.roundtree@emory.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR
404-778-3473
m.k.khan@emory.edu

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.