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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06379581
Other study ID # 2022-04900-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date October 1, 2025

Study information

Verified date April 2024
Source Region Skane
Contact John Albinsson, PhD
Phone 0702497057
Email john.albinsson@med.lu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Department of Ophthamology, Lund, Skåne University Hospital Lund

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor thickness Compare the estimated tumor thickness of tumor lesion with the provided thickness from the histopathological investigation. Enrollment is anticipated to last 1 year + final analyse 6 months
Primary Tumor size Compare the estimated tumor surface size of tumor lesion with the provided thickness from the histopathological investigation. Enrollment is anticipated to last 1 year + final analyse 6 months
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