Spectral Cancer Tissue Recognition - I (SPCTR-I)

March 6, 2026 updated by: SPCTR

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%

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9728NT
        • Recruiting
        • Martini Ziekenhuis
        • Principal Investigator:
          • Wendy Kelder, Dr
    • Utrecht
      • Utrecht, Utrecht, Netherlands, 3584CX
        • Not yet recruiting
        • UMC Utrecht
        • Principal Investigator:
          • Arjen Witkamp, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing breast conserving surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Person that undergoes breast amputation without confirmed cancer diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPCTR

Collaborators

UMC Utrecht
Martini Hospital Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 2025-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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