Margin AssessmentSPCTR-INCT07459062
Spectral Cancer Tissue Recognition - I
An observational study of Margin Assessment and Breast Cancer, run by SPCTR at 2 sites in Netherlands.
Trial summary
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Margin Assessment, Breast Cancer
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- 12 Jan 2026to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing breast conserving surgery
Who may be able to join
- Age ≥18 years
- Confirmed diagnosis breast cancer for which surgical procedure is needed
- Planned for breast conserving surgery
Who cannot join
- Person that undergoes breast amputation without confirmed cancer diagnosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Martini Ziekenhuis
Groningen, Provincie Groningen, 9728NT
Wendy Kelder, Dr
- Not yet recruiting
UMC Utrecht
Utrecht, Utrecht, 3584CX
Arjen Witkamp, Dr.
About this study
Official title: Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able to achieve the following outcomes with classifying tissues:
- Sensitivity (percentage of classified positive margins of actual positive margins): ≥ 96% CI 95.5-97.5%
- Specificity (percentage of classified free margins of actual free margins): 96% CI 95.5-97.5%
- Accuracy (total correctly classified margins): ≥ 96% CI 95.5-97.5%
- Negative predictive value (amount of true negative - free margins - among the classified negative margins): ≥ 95% CI 94.5-96.5%
- Conditions
- Margin Assessment, Breast Cancer
- Medical subject headings
- Breast 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 |
|---|---|---|
| Breadloaf slices | Only sliced specimen are scanned during phase 1 | |
| Whole specimen & Breadloaf slices | Whole specimen and sliced specimen are scanned during phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens
Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start12 Jan 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Margin AssessmentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPCTR
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, Martini Hospital Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459062
- Sponsor's protocol ID
- MEC 2025-115
- Acronym
- SPCTR-I
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT07459062
- Acronym / sponsor ID
- SPCTR-I / MEC 2025-115
- Conditions
- Margin Assessment, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SPCTRIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, Martini Hospital Groningen
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Mar 2026 (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.
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able to achieve the following outcomes with classifying tissues:
- Sensitivity (percentage of classified positive margins of actual positive margins): ≥ 96% CI 95.5-97.5%
- Specificity (percentage of classified free margins of actual free margins): 96% CI 95.5-97.5%
- Accuracy (total correctly classified margins): ≥ 96% CI 95.5-97.5%
- Negative predictive value (amount of true negative - free margins - among the classified negative margins): ≥ 95% CI 94.5-96.5%
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breadloaf slices | – | –Only sliced specimen are scanned during phase 1 |
| Whole specimen & Breadloaf slices | – | –Whole specimen and sliced specimen are scanned during phase 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing breast conserving surgery
Key inclusion criteria (3 listed)
- Age ≥18 years
- Confirmed diagnosis breast cancer for which surgical procedure is needed
- Planned for breast conserving surgery
Key exclusion criteria (1 listed)
- Person that undergoes breast amputation without confirmed cancer diagnosis
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
Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens
Time frame: Through study completion, an average of 6 months
Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Margin Assessment and Breast Cancer, run by SPCTR at 2 sites in Netherlands.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Merjenburgh (+31681119503, robin@spctr.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens (time frame: Through study completion, an average of 6 months). 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 9 Mar 2026.