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

Sponsor

Perimeter Medical Imaging (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05113927

Collaborator

Cancer Prevention Research Institute of Texas (Other), Proxima Clinical Research (Other), Biostatistical Consulting, Inc. (Other)

333

Enrollment

Locations

Arms

Anticipated Duration (Months)

47.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Selene	N/A

Detailed Description

Optical coherence tomography (OCT) -- the optical analogue of high-frequency ultrasound -- is well suited for operative suite decision making because it offers real-time, high-resolution tissue imaging with a penetration depth up to 2 mm. The 2 mm depth of penetration is sufficient to accommodate the current national US (and international) guidelines which state that following resection there should be no tumor "on ink" for invasive cancer and not less than a 2 mm margin for DCIS in the absence of invasive disease. Recently, automated image analysis has demonstrated the potential to both improve diagnostic accuracy and reduce overall assessment time. OCT combined with deep learning algorithms has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions on margin status intraoperatively.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

333 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multi-center, randomized, double-arm trialMulti-center, randomized, double-arm trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The pathologist at each participating site will be blinded to the study arm to ensure that the pathological assessment is unbiased. Additionally, the subject will be blinded to their randomization until the BREAST-Q questionnaire has been completed.

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care Lumpectomy with usual intraoperative margin assessment
Experimental: Device Imaging of all margins with investigational device	Device: Selene 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.

Arm

Intervention/Treatment

No Intervention: Standard of Care

Lumpectomy with usual intraoperative margin assessment

Experimental: Device

Imaging of all margins with investigational device

Device: Selene

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.

Outcome Measures

Primary Outcome Measures

The occurrence of at least one unaddressed positive margin for a subject. [12 months]
Within-subject comparison of the occurrence of subjects with at least one positive margin.

Secondary Outcome Measures

The number of unaddressed positive margins per subject. [12 months]
The average number of unaddressed positive margins per subject.
False Positive Shaves Per Subject [12 months]
The number of false-positive shaves per subject with use of SELENE.

Other Outcome Measures

Safety Outcome - Adverse Events [12 months]
Assessed by recording all adverse events for the duration of the study and then analyzing by seriousness, severity, and device/SELENE procedure-relatedness.
Safety Outcome - Patient Reported Outcome [12 months]
Pre- and Post-operative satisfaction with breasts using the Satisfaction with Breasts subscale score of the BCT module of the patient-reported outcomes measurement instrument BREAST-Q.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Male
Metastatic cancer (Stage IV)
Lobular carcinoma as primary diagnosis
Previous ipsilateral breast surgery for benign or malignant disease (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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
2	Holy Redeemer	Meadowbrook	Pennsylvania	United States	19046
3	West Cancer Center & Research Institute	Germantown	Tennessee	United States	38138
4	St. David's Georgetown Hospital	Georgetown	Texas	United States	78626
5	Baylor College of Medicine	Houston	Texas	United States	77030
6	Methodist Healthcare of San Antonio	San Antonio	Texas	United States	78229
7	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

Perimeter Medical Imaging
Cancer Prevention Research Institute of Texas
Proxima Clinical Research
Biostatistical Consulting, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Perimeter Medical Imaging

ClinicalTrials.gov Identifier:

NCT05113927

Other Study ID Numbers:

PER-19-04

First Posted:

Nov 9, 2021

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Jul 8, 2022