Skin Cancer Diagnostics Using Photoacoustic Imaging

Recruiting

• Conditions: Skin Cancer

• Registration Number: NCT06379581
• Lead Sponsor: Region Skane

Brief Summary

In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

Detailed Description

The study will employ multispectral photoacoustic imaging in the spectral range between 680-970 nm to scan suspected skin tumors both in vivo and ex vivo. The hyperspectral data will then undergo rigorous spectral analysis with the objective to identify the spectral fingerprints associated with healthy tissue and tumor. Thereafter, a classification algorithm will be used to determine whether a pixel in the acquired image more likely identifies with healthy tissue or tumor, which is then repeated for all pixels in the images. As such, a 3D image can be reconstructed in which the tumor is visibly contrasted from healthy tissue. Achieving this goal will facilitate the diagnostic procedures and greatly reduce waiting times, clinical costs and potential patient suffering.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-23
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor thickness	Enrollment is anticipated to last 1 year + final analyse 6 months	Compare the estimated tumor thickness of tumor lesion with the provided thickness from the histopathological investigation.
Tumor size	Enrollment is anticipated to last 1 year + final analyse 6 months	Compare the estimated tumor surface size of tumor lesion with the provided thickness from the histopathological investigation.

Trial Locations

Locations (1)

Department of Ophthamology, Lund, Skåne University Hospital; 🇸🇪 Lund, Sweden