| NCT ID | NCT07459062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SPCTR |
| Condition | Margin Assessment |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-01-12 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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%
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07459062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Margin Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07459062 currently recruiting?
Yes, NCT07459062 is actively recruiting participants. Contact the research team at robin@spctr.tech for enrollment information.
Where is the NCT07459062 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT07459062 clinical trial?
NCT07459062 is sponsored by SPCTR. The trial plans to enroll 100 participants.