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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05113927
Recruitment Status : Recruiting
First Posted : November 9, 2021
Last Update Posted : June 5, 2023
Cancer Prevention Research Institute of Texas
Proxima Clinical Research
Biostatistical Consulting, Inc.
Information provided by (Responsible Party):
Perimeter Medical Imaging

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-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 : December 1, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. The occurrence of at least one unaddressed positive margin for a subject. [ Time Frame: 12 months ]
    Within-subject comparison of the occurrence of subjects with at least one positive margin.

Secondary Outcome Measures :
  1. The number of unaddressed positive margins per subject. [ Time Frame: 12 months ]
    The average number of unaddressed positive margins per subject.

  2. False Positive Shaves Per Subject [ Time Frame: 12 months ]
    The number of false-positive shaves per subject with use of SELENE.

Other Outcome Measures:
  1. Safety Outcome - Adverse Events [ Time Frame: 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.

  2. Safety Outcome - Patient Reported Outcome [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05113927

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Contact: Sarah Butler, PhD 937.416.9886
Contact: David Rempel, B.Sc.,M.Sc. 647.457.4640

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United States, Florida
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Dana Kontras    904-202-7070   
Principal Investigator: Laila Samiian, MD         
Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Sevara Fazilova   
Principal Investigator: Marie Lee         
Sub-Investigator: Brian Czernecki         
United States, Pennsylvania
Holy Redeemer Recruiting
Meadowbrook, Pennsylvania, United States, 19046
Contact: Nadine Varney    215-544-5832   
Principal Investigator: Stacy Krisher         
Sub-Investigator: Anna M Mazor         
Sub-Investigator: Malini Iyer         
United States, Tennessee
West Cancer Center & Research Institute Active, not recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Kelly Liao    972-566-2321   
Principal Investigator: Allison DiPasquale         
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Methodist Healthcare of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: JoDell McCracken    210-575-4281   
Principal Investigator: Maryam Elmi         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Sophie Oubaha    608-262-1551   
Principal Investigator: Lee Wilke         
Sub-Investigator: Meeghan Lautner         
Sponsors and Collaborators
Perimeter Medical Imaging
Cancer Prevention Research Institute of Texas
Proxima Clinical Research
Biostatistical Consulting, Inc.
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Responsible Party: Perimeter Medical Imaging Identifier: NCT05113927    
Other Study ID Numbers: PER-19-04
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes