Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

A study testing Selene in people with Breast Cancer, run by Perimeter Medical Imaging at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Selene
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 613 participants
Where: 10 sitesUnited States
Study dates: 1 Dec 2021to 21 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female
Age 18 years or older
Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
Ability to understand and the willingness to sign a written informed consent document

Who cannot join

Male
Metastatic cancer (Stage IV)
Lobular carcinoma as primary diagnosis
Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation)
Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
Subjects with bilateral disease (diagnosed cancer in both breasts)

Show all 11Show fewer

Participating in any other investigational margin assessment study which can influence collection of valid data under this study
Use of cryo-assisted localization
Currently lactating
Current pregnancy
Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Medical City Dallas
Dallas, Texas, 75230
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
Baylor College of Medicine
Houston, Texas, 77030
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Mayo Clinic
Jacksonville, Florida, 32224
University of Wisconsin
Madison, Wisconsin, 53792
Holy Redeemer
Meadowbrook, Pennsylvania, 19046
Methodist Healthcare of San Antonio
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98195
Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

Conditions: Breast Cancer
Being tested: Selene
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SeleneDevice
SELENE imaging of all margins, with record of each margin assessment and an opportunity to excise tissue from the lumpectomy cavity post-imaging. The new margin will be imaged with SELENE and the surgeon will record the assessment and may take additional tissue (up to a maximum of six total shaves, including up to two shaves in each orientation) or record why no further tissue may be taken.

Study groups in NCT05113927
Study group	Role	What they receive
Standard of Care	No intervention	Lumpectomy with usual intraoperative margin assessment
Device	Experimental	Imaging of all margins with investigational device Receives: Device: Selene

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With at Least One Unaddressed Positive Margin
This endpoint is a within-subject comparison of the occurrence of at least one unaddressed positive margin following standard of care (SOC) alone versus after the adjunctive use of the device (SOC + Device).
An "unaddressed margin" is an actionable margin where the surgeon could have excised additional tissue but which is determined to be positive by pathology.
Positive margin criteria follow NCCN and SSO/ASTRO guidelines: "ink on tumor" for invasive carcinoma and < 2 mm for DCIS.
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Secondary outcomes (6)

The Number of Unaddressed Positive Margins Per Subject.
This measure is a within-subject comparison of the mean number of unaddressed positive margins determined through histopathology following SOC treatment alone versus SOC + Device use. An "unaddressed margin" is defined as a final margin where further tissue could have been excised but which was determined to be positive by pathology.
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
False Positive Shaves Per Subject
A within-subject comparison of the number of "false-positive" shaves, defined as any shave where pathology reported no presence of cancer (cancer-free), taken during SOC alone vs. the supplemental use of the Device.
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Margin-level Effectiveness (National Guidelines)
According to the joint consensus guidelines by the Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO), a positive margin for invasive carcinoma is defined as "ink on tumor" (1). For ductal carcinoma in situ (DCIS), including DCIS with microinvasion (DCISM), the NCCN defines a positive margin as <2 mm and DCIS with microinvasion is further characterized as an invasive focus ≤1 mm in size) (2). For cases involving invasive carcinoma with a DCIS component, the SSO/ASTRO Guidelines apply the same definition of a positive margin-"ink on tumor"-to both invasive carcinoma and DCIS. Similarly, for participants who have undergone neo-adjuvant therapy, the "ink on tumor" definition is used for both invasive carcinoma and DCIS
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Margin-level Effectiveness (National Guidelines) (Continued)
A post-hoc analysis was conducted to assess accuracy as an additional measure of margin-level effectiveness for clinical decisions aided by the B-Series, with the following definition in the Full Analysis Set based on terms as defined in SAP Table 1b, where T=true, F=false, M=missing, P=positive, and N=negative. Clinical decision accuracy = (TP+TN)/(TP+TN+FN+FP+MP+MN).
This analysis does not reflect true (per margin) sensitivity or specificity of device standalone performance but instead measures clinical decisions aided with the Device after SOC was completed.
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Subject-Level Effectiveness (Pathology Guidelines)
Subject-Level Effectiveness of Clinical Decisions aided with Device on Final SOC Margins with "Ground Truth" Pathology results Based on NCCN and SSO/ASTRO Guidelines
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Subject-level Effectiveness (Pathology Guidelines) (Continued)
This analysis does not reflect true (per subject) sensitivity or specificity of device standalone performance but instead measures clinical decisions aided with the Device after SOC was completed.
Measured: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202121 Oct 2024

First posted9 Nov 2021
Study start1 Dec 2021
Primary completion23 Sep 2024
Study completion21 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multi-center, randomized, double-arm trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05113927
Sponsor's protocol ID: PER-19-04
Acronym: RCT
Status last verified: Jul 2026
First submitted: 2 Nov 2021
Last updated: 13 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
ClinicalTrials.gov ID: NCT05113927
Acronym / sponsor ID: RCT / PER-19-04
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 613 participants (actual)
Lead sponsor: Perimeter Medical ImagingIndustry (pharma, biotech, devices)
Collaborators: Cancer Prevention Research Institute of Texas, Proxima CRO, Biostatistical Consulting, Inc.
Study start: 1 Dec 2021 (actual)
Primary completion: 23 Sep 2024 (actual)
Study completion: 21 Oct 2024 (actual)
First posted: 9 Nov 2021 (actual)
Results: Posted 13 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Multi-center, randomized, double-arm trial

Arm	Type	Receives
Standard of Care	No intervention	–Lumpectomy with usual intraoperative margin assessment
Device	Experimental	Device: SeleneImaging of all margins with investigational device

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Female
Age 18 years or older
Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
Ability to understand and the willingness to sign a written informed consent document

Key exclusion criteria (11 listed)

Male
Metastatic cancer (Stage IV)
Lobular carcinoma as primary diagnosis
Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation)
Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SeleneSELENE imaging of all margins, with record of each margin assessment and an opportunity to excise tissue from the lumpectomy cavity post-imaging. The new margin will be imaged with SELENE and the surgeon will record the assessment and may take additional tissue (up to a maximum of six total shaves, including up to two shaves in each orientation) or record why no further tissue may be taken.	Device	Device

Primary outcome

Participants With at Least One Unaddressed Positive Margin
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
This endpoint is a within-subject comparison of the occurrence of at least one unaddressed positive margin following standard of care (SOC) alone versus after the adjunctive use of the device (SOC + Device). An "unaddressed margin" is an actionable margin where the surgeon could have excised additional tissue but which is determined to be positive by pathology. Positive margin criteria follow NCCN and SSO/ASTRO guidelines: "ink on tumor" for invasive carcinoma and < 2 mm for DCIS.

6 secondary outcomes

The Number of Unaddressed Positive Margins Per Subject.
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
False Positive Shaves Per Subject
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Margin-level Effectiveness (National Guidelines)
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Margin-level Effectiveness (National Guidelines) (Continued)
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Subject-Level Effectiveness (Pathology Guidelines)
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
Subject-level Effectiveness (Pathology Guidelines) (Continued)
Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Results and safety

Results posted to the registry on 13 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Training Group	133	133
Device	317	315
Control	165	165

Primary outcome: Participants With at Least One Unaddressed Positive Margin

Time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery). Count of participants. Unit: Participants

Measure	Device (Per-Protocol Set) n = 202
After SOC: ≥1 Unaddressed positive margins	33
After SOC: 0 Unaddressed positive margins	169
After SOC + Device: ≥1 Unaddressed positive margins	26
After SOC + Device: 0 Unaddressed positive margins	176

Device (Per-Protocol Set): p = 0.0045, One-sided exact binomial test
Device (Per-Protocol Set): p = 0.2876, Fisher Exact

Population analysed: The Per Protocol Analysis Set (PPS) includes Part B Device Arm participants with a final pathology report, OCT imaging, and no major protocol deviations. An independent, blinded breast surgeon adjudicated deviations to ensure objectivity.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: At the time of Index Surgery through Post-Operative Follow Up Visit and concluded with the completion of the post-operation BREAST-Q questionnaire for each enrolled participant, conducted between 4 and 12 weeks post-surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Training Group	1 of 133 (0.8%)	36 of 133 (27.1%)	0 of 133
Device	2 of 317 (0.6%)	88 of 317 (27.8%)	0 of 317
Control	2 of 163 (1.2%)	48 of 163 (29.4%)	1 of 163

Limitations and caveats (from the sponsor): Device use occurred only after standard of care (SOC) modalities were exhausted, limiting detection opportunities to residual disease missed by SOC. Performance metrics reflect clinical decisions aided by the device within the surgical workflow rather than standalone device efficacy. Findings may not be directly comparable to other technologies. Finally, while powered for the primary endpoint, the sample size may limit subgroup analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

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Not yet recruitingObservational study
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RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Selene in people with Breast Cancer, run by Perimeter Medical Imaging at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With at Least One Unaddressed Positive Margin (time frame: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05113927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.