Spectral Cancer Tissue Recognition - I
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSPCTR
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Confirmed diagnosis breast cancer for which surgical procedure is needed
Planned for breast conserving surgery
Disqualifiers
Person that undergoes breast amputation without confirmed cancer diagnosis
Trial population
Patients undergoing breast conserving surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Breadloaf slices
Group B: Whole specimen & Breadloaf slices
Trial outcomes
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.
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov