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A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers (BCL)

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: NCT03573661
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Brief Summary:
Our objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.

Condition or disease Intervention/treatment Phase
Palpable Breast Cancer Device: Breast Cancer Locator (BCL) Not Applicable

Detailed Description:

The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with the patient lying flat on their back (just as they are on an operating room table). The BCL is then custom made for the patient using 3D printing technology.

The cancer can be felt by the surgeon, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not need an image guidance system such as the BCL to locate the cancer in the breast. Other women may have breast cancers that cannot be felt identified by mammography or MRI. If the BCL proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women.

Additionally, we want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. The BCL has been used in 19 patients at Dartmouth with no complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Breast Cancer Locator (BCL)
The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.
Device: Breast Cancer Locator (BCL)
This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.

Primary Outcome Measures :
  1. Determine the proportion of patients who will have had the localization wire deployed within the cancer on the specimen mammogram. [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. Whether the study Radiologist can accurately segment the tumor from the supine MRI images that are provided. [ Time Frame: 30 Days ]
  2. Time from supine MRI to delivery of the BCL to the surgeon. [ Time Frame: 30 Days ]
  3. Whether the BCL enabled the surgeon to successfully place all surgical cues in/on the breast (tumor edges, blue dye injections and hook wire placement). [ Time Frame: 30 Days ]
  4. Lumpectomy specimen volumes. [ Time Frame: 30 Days ]
  5. Operative times. [ Time Frame: 30 Days ]
  6. The pathologic tumor margins (distance from the tumor to the specimen edge). [ Time Frame: 30 Days ]
  7. Complications from surgery. [ Time Frame: 30 Days ]
  8. Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator. [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 18 years.
  2. Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.
  3. Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).
  4. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
  5. The cancer enhances on prone breast MRI imaging
  6. The cancer is visible on mammography.

Exclusion Criteria:

  1. Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
  2. Severe claustrophobia.
  3. Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine > 2.0).
  4. History of median sternotomy.
  5. Pregnancy. Patient attestation that they are not pregnant will be acceptable.
  6. Patients receiving neoadjuvant chemotherapy.

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): NCT03573661

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Contact: Tanya M PERRY, BS, CCRP 603-650-6056

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United States, Massachusetts
Lahey Hospital & Medical Center (Lahey Clinic) Not yet recruiting
Burlington, Massachusetts, United States, 01805
United States, New Hampshire
Cheshire Medical Center Not yet recruiting
Keene, New Hampshire, United States, 03431
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Richard J Barth, MD    800-639-6918   
Contact: Research Nurse    800-639-6918   
St. Joseph Hospital Not yet recruiting
Nashua, New Hampshire, United States, 03060
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

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Responsible Party: Richard J. Barth,Jr., MD, Dartmouth-Hitchcock Medical Center Identifier: NCT03573661     History of Changes
Other Study ID Numbers: D16196
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:
Breast Conserving Surgery
Breast Imaging
Breast Cancer Locator
Supine MRI

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases