Optical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions
NCT ID: NCT07213154
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-10-15
2027-09-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
Quantitative Oblique Back-Illumination Microscopy
Undergo qOBM
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.
Quantitative Oblique Back-Illumination Microscopy
Undergo qOBM
Radiation Therapy
Undergo SOC RT
Interventions
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Quantitative Oblique Back-Illumination Microscopy
Undergo qOBM
Radiation Therapy
Undergo SOC RT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate with skin lesions
* Signed study-specific informed consent prior to study entry
* ≥ 18 years old
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Mohammad K. Khan
Principal Investigator
Principal Investigators
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Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-02356
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00008502
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP6407-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00008502
Identifier Type: -
Identifier Source: org_study_id