Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)

NCT04314700 | Terminated FDA Device

• 1 other identifier: PER-19-02
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (3)

• Number of times the surgeon recorded a decision to excise additional tissue based on intra-operative Wide Field Optical Coherence Tomography (WF-OCT) image review in addition to Standard of Care tissue assessment.

  Surgeon's assessment of margin status post Wide Field OCT (WF-OCT) image review and any action taken, will be recorded.

  Within 1 hour of tissue excision

• Average time to excise additional tissue during Breast Conserving Surgery (BCS)

  Time taken to excise additional tissue based on WF-OCT image review, will be recorded.

  Within 1 hour of primary tumor excision

• Calculate percentage of patients that require a second surgery

  Record percentage of patients with positive margins per pathology, that require a second surgery.

  Within about 3 months of first surgery

Study Arms (1)

OCT imaging and review of excised breast lumpectomy tissue

OTHER

Device: OCT- based investigational imaging device

Interventions

OCT- based investigational imaging device DEVICE

Excised breast lumpectomy tissue will be imaged and images reviewed on an investigational Wide-Field OCT (WF-OCT) device.

OCT imaging and review of excised breast lumpectomy tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female age 18 or older
• Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ
• May include subjects treated with neo-adjuvant endocrine therapy
• May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Male
• Stage IV breast cancer
• Participation in another study that prolongs time to pathologic processing (greater than 1 hour)
• Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response
• A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded).
• Use of cryosurgery
• Currently lactating
• Current pregnancy
• Previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery

Sponsors & Collaborators

• Perimeter Medical Imaging: lead

Study Sites (1)

Northern Arizona Healthcare

Cottonwood, Arizona, 86326, United States

Location

Study Officials

• Beth DuPree, MD

  Northern Arizona Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 19, 2020
• Study Start: February 11, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 7, 2021
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: During the study and post study completion
• Access Criteria: Research and development/product development purposes.

Locations

US (1)