Spectral Cancer Tissue Recognition - I | NCT07459062

Studies
Spectral Cancer Tissue Recognition - I

NCT07459062

Sponsor

SPCTR

Status

Recruiting

Last Update Posted

Mar 9, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Margin Assessment
Breast Cancer

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2026Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 6, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 9, 2026Actual

Name	Class
UMC Utrecht	OTHER
Martini Hospital Groningen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breadloaf slices		Only sliced specimen are scanned during phase 1
Whole specimen & Breadloaf slices		Whole specimen and sliced specimen are scanned during phase 2

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing breast conserving surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robin Merjenburgh	Contact	+31681119503		robin@spctr.tech

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martini Ziekenhuis	Recruiting	Groningen	Provincie Groningen	9728NT	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided