Optical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative Oblique Back-Illumination Microscopy, Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Malignant Skin Neoplasm, Skin Disorder, Skin Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions
Overview
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
- Procedure Quantitative Oblique Back-Illumination Microscopy
Undergo qOBM - Radiation Radiation Therapy
Undergo SOC RT
Primary outcome measures
- qOBM Clinical Assessment [Time frame: Up to 12 months]
Secondary outcome measures (1)
- Usability of the qOBM Device [Time frame: Up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
Identifiers
NCT: NCT07213154 · STUDY00008502 · NCI-2025-02356 · STUDY00008502 · WINSHIP6407-24 · P30CA138292