Optical Imaging Scans for Skin Cancer

Not yet recruiting at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Prior surgery, Radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called quantitative oblique back-illumination microscopy (qOBM) to aid in diagnosing skin cancer. It uses red light to scan skin lesions, potentially making it easier for doctors to detect cancer. The trial targets individuals with skin spots that might be cancerous or abnormal. Participants will undergo one or more qOBM scans, and those diagnosed with skin cancer may receive additional scans alongside their standard treatment. This trial suits adults with skin lesions who have not undergone surgery or radiotherapy on the area being examined. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance skin cancer diagnosis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this optical imaging scan is safe for diagnosing skin cancer?

Studies have shown that quantitative oblique back-illumination microscopy (qOBM) is a non-invasive procedure, meaning it doesn't involve cutting into the body or removing tissue. Instead, it uses red light to help doctors see skin spots more clearly.

Research suggests that qOBM is comfortable for patients. As a non-invasive method, it has not been associated with serious side effects or discomfort. It’s akin to having a photo taken with a special light, making it a safe option for examining skin spots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Quantitative Oblique Back-Illumination Microscopy (qOBM) is unique because it offers a non-invasive way to image skin cancer, potentially providing more detailed information than traditional biopsy methods. Unlike standard treatments that often involve surgical procedures or radiation, qOBM uses light to create high-resolution images of skin lesions, which could help in diagnosing skin cancer more accurately and quickly. Researchers are excited about this trial as it could lead to a more efficient and less invasive method for monitoring and diagnosing skin cancer, ultimately improving patient outcomes and reducing the need for unnecessary treatments.

What evidence suggests that quantitative oblique back-illumination microscopy is effective for diagnosing skin cancer?

This trial will evaluate the effectiveness of quantitative oblique back-illumination microscopy (qOBM) in diagnosing skin conditions, including cancer. Research has shown that qOBM can examine various skin conditions without cutting the skin. It uses red light to capture detailed images, aiding doctors in identifying changes that might indicate cancer. Participants in this trial will undergo qOBM optical imaging scans, and those diagnosed with skin cancer may receive additional scans alongside standard-of-care radiation therapy. The images from qOBM are clear and comparable to those from traditional methods, suggesting that qOBM could be a valuable tool for diagnosing skin cancer more effectively. ^{6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with skin lesions who may have conditions like dermatitis or skin cancer. It aims to help doctors diagnose these issues more accurately using a non-invasive imaging scan.

Inclusion Criteria

Signed study-specific informed consent prior to study entry

I am 18 years old or older.

I am either male or female.

Exclusion Criteria

I have had surgery or radiation on the area that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

qOBM Imaging

Patients undergo qOBM optical imaging scans to assess skin lesions

Up to 12 months

3 visits (in-person) at the discretion of the treating physician

Radiation Therapy

Patients with skin cancer undergo standard of care radiation therapy with qOBM imaging scans before, during, or after treatment

Varies based on SOC RT schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Additional qOBM scans at approximately 1, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative Oblique Back-Illumination Microscopy

Trial Overview The study is testing the effectiveness of quantitative oblique back-illumination microscopy (qOBM), which uses red light to examine skin lesions, compared to traditional diagnostic methods without imaging.

How Is the Trial Designed?

Group I: Group II (qOBM, SOC RT) Experimental Treatment 2 Interventions

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.

Group II: Group I (qOBM) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40766649/

Single Capture Quantitative Oblique Back-Illumination ... We demonstrate that SCqOBM achieves remarkable phase imaging accuracy, closely matching the results of traditional four-capture qOBM in diverse ...

2. biorxiv.org biorxiv.org/content/10.1101/2025.09.17.675943v1.full.pdf

Label-Free, Real-Time, In Vivo Optical Biopsy with a ... The approach uses quantitative oblique back illumination microscopy (qOBM) to obtain quantitative phase information of opaque samples using epi- ...

3. researchgate.net researchgate.net/publication/369322573_Quantitative_oblique_back-illumination_microscopy_with_enhanced_nuclear_phase_contrast_using_acetic_acid

(PDF) Quantitative oblique back-illumination microscopy ... Data from a bulk and infiltrative brain tumor animal model show that qOBM enables quantitative phase imaging of thick fresh brain tissues with remarkable ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/555717-optical-imaging-scans-for-the-diagnosis-of-skin-cancer-in-patients-with-lesions

Innovative Skin Imaging Study Using New qOBM Technology ... First-in-human study evaluating innovative qOBM handheld imaging technology for non-invasive assessment of skin lesions including cancers, benign conditions ...

5. ctv.veeva.com ctv.veeva.com/study/optical-imaging-scans-for-the-diagnosis-of-skin-cancer-in-patients-with-lesions

Optical Imaging Scans for the Diagnosis of Skin Cancer in ... qOBM is a non-invasive procedure that uses red light for illumination, and may work better than no imaging procedures in aiding doctors in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39346989/

GAN-based quantitative oblique back-illumination ... qOBM is a novel imaging technology that enables epi-mode 3D quantitative phase imaging and refractive index (RI) tomography of thick scattering samples.

7. mdpi.com mdpi.com/1424-8220/21/1/252

Optical Technologies for the Improvement of Skin Cancer ... This paper reviews a variety of the optical modalities that have been used in the last years in order to improve non-invasive diagnosis of skin cancer.

8. spiedigitallibrary.org spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-29/issue-S1/S11518/Photoacoustic-imaging-for-cutaneous-melanoma-assessment-a-comprehensive-review/10.1117/1.JBO.29.S1.S11518.full

Photoacoustic imaging for cutaneous melanoma assessment PAI holds great clinical potential as a noninvasive technique for melanoma detection and disease management. PA microscopy has predominantly been used to image ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8103840/

Comparative Analysis of Diagnostic Techniques for ... This review aims to compare the diagnostic performance of non-invasive techniques, alternative to dermoscopy, for melanoma detection in clinical settings.