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.|
|ClinicalTrials.gov Identifier: NCT03573661|
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Palpable Breast Cancer||Device: Breast Cancer Locator (BCL)||Not Applicable|
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.
|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|
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.
- Determine the proportion of patients who will have had the localization wire deployed within the cancer on the specimen mammogram. [ Time Frame: 30 Days ]
- Whether the study Radiologist can accurately segment the tumor from the supine MRI images that are provided. [ Time Frame: 30 Days ]
- Time from supine MRI to delivery of the BCL to the surgeon. [ Time Frame: 30 Days ]
- 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 ]
- Lumpectomy specimen volumes. [ Time Frame: 30 Days ]
- Operative times. [ Time Frame: 30 Days ]
- The pathologic tumor margins (distance from the tumor to the specimen edge). [ Time Frame: 30 Days ]
- Complications from surgery. [ Time Frame: 30 Days ]
- Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator. [ Time Frame: 30 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT03573661
|Contact: Tanya M PERRY, BS, CCRPfirstname.lastname@example.org|
|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 Richard.J.Barth@hitchcock.org|
|Contact: Research Nurse 800-639-6918 email@example.com|
|St. Joseph Hospital||Not yet recruiting|
|Nashua, New Hampshire, United States, 03060|