Handheld red‑light optical scan to help diagnose skin lesions
Assessment of Novel Label-free Optical Imaging Technology for the Evaluation of Skin Lesions
This trial tests a handheld red‑light optical scan (qOBM) to see if it helps doctors diagnose skin cancer in adults with skin lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT07213154 on ClinicalTrials.gov |
What this trial studies
This first‑in‑human study uses a handheld quantitative oblique back‑illumination microscopy (qOBM) device that noninvasively images skin lesions with red light in situ and in vivo. Adult patients with a range of skin lesions, including suspected melanoma or dysplastic nevi, will undergo qOBM imaging and some may receive additional scans as determined by their physician. When lesions are biopsied or surgically removed, optical findings will be compared with histology to characterize features such as lesion margins, depth, pigmentation, and changes in surrounding tissue. Secondary aims include cataloguing malignant, benign, and inflammatory lesion appearances and documenting pre‑ and post‑treatment tissue changes.
Who should consider this trial
Good fit: Adults aged 18 or older with skin lesions, including suspected melanoma or dysplastic nevi, who can give informed consent and have not had prior surgery or radiotherapy to the area are ideal candidates.
Not a fit: People under 18, or those who have had prior surgery or radiation to the area being imaged, are excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, qOBM could provide a quick, noninvasive way to distinguish malignant from benign skin lesions and reduce unnecessary biopsies and procedures.
How similar studies have performed: This is the first‑in‑human test of qOBM specifically, although other optical imaging techniques such as reflectance confocal microscopy and optical coherence tomography have shown promise in aiding skin lesion diagnosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Mohammad K. Khan, MD, PhD, MS, FACRO, FACR, DABR
- Email: m.k.khan@emory.edu
- Phone: 404-778-3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.