NCT06379581

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2023Oct 2027

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 1, 2026

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

April 17, 2024

Last Update Submit

April 27, 2026

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Patients with suspected skin tumors

With the help of photoacoustic imaging (PAI), determine the border between healthy tissue and tumor by determining the difference in chromophoric composition by their difference in absorption spectral features.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to perform surgical excision of lesion(s) at the Clinic of Dermatology, Lund, Skåne University Hospital

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthamology, Lund, Skåne University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 23, 2024

Study Start

January 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

May 1, 2026

Record last verified: 2025-09

Locations

SE(1)