Skin CancerNCT06379581
Skin Cancer Diagnostics Using Photoacoustic Imaging
An observational study of Skin Cancer, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Cancer
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to 1 Oct 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled to perform surgical excision of lesion(s) at the Clinic of Dermatology, Lund, Skåne University Hospital
Who may be able to join
- Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Ophthamology, Lund, Skåne University Hospital
Lund, 22185
About this study
Official title: Photoacoustic Imaging for Three-dimensional Delineation of Skin Tumors
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.
Read the 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.
- Conditions
- Skin Cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor thickness
Compare the estimated tumor thickness of tumor lesion with the provided thickness from the histopathological investigation.
Measured: 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.
Measured: Enrollment is anticipated to last 1 year + final analyse 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: Lack of available personnel for recruitment of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379581
- Sponsor's protocol ID
- 2022-04900-02
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Imaging for Three-dimensional Delineation of Skin Tumors
- ClinicalTrials.gov ID
- NCT06379581
- Acronym / sponsor ID
- 2022-04900-02
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Lack of available personnel for recruitment of patients.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled to perform surgical excision of lesion(s) at the Clinic of Dermatology, Lund, Skåne University Hospital
Key inclusion criteria (1 listed)
- Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor thickness
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor thickness (time frame: Enrollment is anticipated to last 1 year + final analyse 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.