NCT07459062

Brief 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 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%

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Start

First participant enrolled

January 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 3, 2026

Last Update Submit

March 6, 2026

Conditions

Margin AssessmentBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens

    Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.

    Through study completion, an average of 6 months

Study Arms (2)

Breadloaf slices

Only sliced specimen are scanned during phase 1

Whole specimen & Breadloaf slices

Whole specimen and sliced specimen are scanned during phase 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing breast conserving surgery

You may qualify if:

  • Age ≥18 years
  • Confirmed diagnosis breast cancer for which surgical procedure is needed
  • Planned for breast conserving surgery

You may not qualify if:

  • Person that undergoes breast amputation without confirmed cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martini Ziekenhuis

Groningen, Provincie Groningen, 9728NT, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Robin Merjenburgh

CONTACT

+31681119503robin@spctr.tech

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

January 12, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

NL(2)