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Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Breast Cancer Locator (BCL) guided partial mastectomy
Wire Localized (WL) partial mastectomy
Sponsored by
CairnSurgical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female gender
  • Age > 18 years
  • Histologic diagnosis of invasive breast cancer or DCIS
  • The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
  • The tumor is unifocal; possible satellite lesions < or = 2 cm from primary are eligible
  • The tumor enhances on prone breast MRI imaging
  • The tumor is ≥ 1 cm in diameter on mammography or prone MRI
  • Subject and surgeon agree to perform BCS
  • Ability to voluntarily provide informed consent

Exclusion Criteria:

  • Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
  • Severe claustrophobia
  • Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
  • Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
  • Pregnancy - In women of childbearing age a urine pregnancy test will be performed
  • Subjects who have received or plan to receive neoadjuvant chemotherapy
  • Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position
  • Measurement of widest circumference around breasts and arms > 135 cm
  • Subjects with known allergy to materials present in the device
  • Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
  • Subject would require > 2 localization wires, if randomized to standard of care
  • Multicentric tumors (additional tumors > 2 cm from primary)

Sites / Locations

  • Arizona Center for Cancer CareRecruiting
  • Baptist MD Anderson Cancer CenterRecruiting
  • Moffitt Cancer Center
  • Tufts Medical CenterRecruiting
  • Mass General/North Shore Center for Outpatient CareRecruiting
  • Steward Medical GroupRecruiting
  • Hennepin HealthcareRecruiting
  • Cheshire Medical CenterRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • Catholic Medical CenterRecruiting
  • St. Joseph HospitalRecruiting
  • Summit HealthRecruiting
  • St. Peter's HospitalRecruiting
  • Kings County Hospital Center
  • Columbia University Irving Medical Center and New York-Presbyterian Hospital
  • Montefiore Nyack Hospital
  • Women and Infants HospitalRecruiting
  • Kent HospitalRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Southwestern Vermont Medical Center
  • Rutland Regional Medical Center
  • Princess Margaret Cancer Centre
  • Royal Free London NHS Trust
  • Manchester University NHSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breast Cancer Locator (BCL)

Wire Localization (WL)

Arm Description

Subject randomized to BCL surgical guidance to perform partial mastectomy

Subject randomized to WL surgical guidance to perform partial mastectomy

Outcomes

Primary Outcome Measures

Positive margin rate
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance

Secondary Outcome Measures

Specimen volumes
To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
Re-excision rate
To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
Cancer localization rate
To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
Operative times
To compare operative times for women randomized to BCL vs. WL-guided BCS
Adverse event rate
To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
Rate of additional shave biopsies
To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
Costs of care
To compare costs of care for women randomized to BCL vs. WL-guided BCS

Full Information

First Posted
May 15, 2020
Last Updated
August 17, 2023
Sponsor
CairnSurgical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04397185
Brief Title
Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Official Title
Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CairnSurgical, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
Detailed Description
The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS. Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Pathologist will be blinded to the study assignment (BCL vs. WL)
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer Locator (BCL)
Arm Type
Experimental
Arm Description
Subject randomized to BCL surgical guidance to perform partial mastectomy
Arm Title
Wire Localization (WL)
Arm Type
Active Comparator
Arm Description
Subject randomized to WL surgical guidance to perform partial mastectomy
Intervention Type
Device
Intervention Name(s)
Breast Cancer Locator (BCL) guided partial mastectomy
Intervention Description
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Intervention Type
Device
Intervention Name(s)
Wire Localized (WL) partial mastectomy
Intervention Description
Standard of care procedure
Primary Outcome Measure Information:
Title
Positive margin rate
Description
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary Outcome Measure Information:
Title
Specimen volumes
Description
To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Re-excision rate
Description
To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Cancer localization rate
Description
To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Operative times
Description
To compare operative times for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Adverse event rate
Description
To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Rate of additional shave biopsies
Description
To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled
Title
Costs of care
Description
To compare costs of care for women randomized to BCL vs. WL-guided BCS
Time Frame
At completion of study recruitment, approximately 18 months after first subject enrolled

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female gender Age > 18 years Histologic diagnosis of invasive breast cancer or DCIS The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation The tumor is unifocal; possible satellite lesions < or = 2 cm from primary are eligible The tumor enhances on prone breast MRI imaging The tumor is ≥ 1 cm in diameter on mammography or prone MRI Subject and surgeon agree to perform BCS Ability to voluntarily provide informed consent Exclusion Criteria: Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes Severe claustrophobia Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury Pregnancy - In women of childbearing age a urine pregnancy test will be performed Subjects who have received or plan to receive neoadjuvant chemotherapy Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position Measurement of widest circumference around breasts and arms > 135 cm Subjects with known allergy to materials present in the device Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe) Subject would require > 2 localization wires, if randomized to standard of care Multicentric tumors (additional tumors > 2 cm from primary)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jodie Ploetz, MA
Phone
303-656-0560
Email
jploetz@cairnsurgical.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Danielsen
Phone
508-736-0283
Email
danielsen@cairnsurgical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Gass, MD
Organizational Affiliation
Women & Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Center for Cancer Care
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Labriola
Phone
480-278-8261
Email
Penny.Labriola@arizonaccc.com
First Name & Middle Initial & Last Name & Degree
Sommer R. Gunia, DO
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Kontras, MSN, RN
Phone
904-202-7070
Email
Dana.Kontras@bmcjax.com
First Name & Middle Initial & Last Name & Degree
Laila Samiian, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Gomez
Email
sgomez3@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Sarah Persing, MD
Facility Name
Mass General/North Shore Center for Outpatient Care
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Manzi
Email
camanzi@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Rebecca Kwait, MD
Facility Name
Steward Medical Group
City
Easton
State/Province
Massachusetts
ZIP/Postal Code
02356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cat Melendy, BSN, RN
Phone
774-568-8534
Email
Catherine.Melendy@steward.org
First Name & Middle Initial & Last Name & Degree
Kerry Bennett, MD
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Colonna
Email
Emily.Colonna@hcmed.org
First Name & Middle Initial & Last Name & Degree
Abigail Madans, DO
Facility Name
Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Lynch
First Name & Middle Initial & Last Name & Degree
H.E. Guy Burman, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel M. Wierzbicki, MD
Email
rachel.m.wierzbicki@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Kari Rosenkranz
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Jensen
Email
emily.jensen@cmc-nh.org
First Name & Middle Initial & Last Name & Degree
Jessica Ryan, MD
First Name & Middle Initial & Last Name & Degree
Jessica Ryan, MD
Facility Name
St. Joseph Hospital
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Gnerre, RN
Phone
603-884-4171
Email
agnerre@sjhnh.org
First Name & Middle Initial & Last Name & Degree
Stacey Abbis, MD
Facility Name
Summit Health
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Remuszka, RN, BSN
Phone
973-436-1748
Email
jremuszka@summithealth.com
First Name & Middle Initial & Last Name & Degree
Winnie Polen, DO
Facility Name
St. Peter's Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khadija Rafiqi
Phone
518-525-6739
Email
khadija.rafiqi@sphp.com
First Name & Middle Initial & Last Name & Degree
Sarah Pesek, MD
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11207
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University Irving Medical Center and New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherene Ishtihar
Phone
212-342-3681
Email
si2271@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Bret Taback, MD
Facility Name
Montefiore Nyack Hospital
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Withdrawn
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Locke
Phone
401-430-8181
Email
ELocke@Wihri.org
First Name & Middle Initial & Last Name & Degree
David Edmonson, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Gass, MD
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Rotondo, MBA
Phone
401-737-7000
Ext
31857
Email
JRotondo@KentRI.org
First Name & Middle Initial & Last Name & Degree
Jamie Patterson, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantell M Farinas
Phone
713-563-4560
Email
cfarinas@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Kelly Hunt, MD
Facility Name
Southwestern Vermont Medical Center
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rutland Regional Medical Center
City
Rutland
State/Province
Vermont
ZIP/Postal Code
05701
Country
United States
Individual Site Status
Terminated
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wey-Liang Leong
First Name & Middle Initial & Last Name & Degree
Wey-Liang Leong
Facility Name
Royal Free London NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muneer Ahmed, MB BS MA PhD
First Name & Middle Initial & Last Name & Degree
Muneer Ahmed, MB BS MA PhD
Facility Name
Manchester University NHS
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Harvey, MBBS PhD
First Name & Middle Initial & Last Name & Degree
James Harvey, MBBS PhD

12. IPD Sharing Statement

Learn more about this trial

Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

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