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

NCT07213154 | Recruiting FDA Device

• 4 other identifiers: STUDY00008502NCI-2025-02356WINSHIP6407-24P30CA138292
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Skin Neoplasm; Skin Disorder; Skin Neoplasm

Outcome Measures

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

  Up to 12 months

Secondary Outcomes (1)

• Usability of the qOBM Device

  Up to 12 months

Study Arms (2)

Group I (qOBM)

EXPERIMENTAL

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

Group II (qOBM, SOC RT)

EXPERIMENTAL

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; Radiation: Radiation Therapy

Interventions

Quantitative Oblique Back-Illumination Microscopy PROCEDURE

Undergo qOBM

Also known as: qOBM

Group I (qOBM); Group II (qOBM, SOC RT)

Radiation Therapy RADIATION

Undergo SOC RT

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Group II (qOBM, SOC RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Candidate with skin lesions
• Signed study-specific informed consent prior to study entry
• ≥ 18 years old

You may not qualify if:

• Prior surgery or radiotherapy to the area to be treated

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Skin Diseases

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR

CONTACT

404-778-3473; m.k.khan@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: October 8, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (2)