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

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ClinicalTrials.gov Identifier: NCT02550210
Recruitment Status : Completed
First Posted : September 15, 2015
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Device: Breast Cancer Locator (BCL)
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Period Title: Overall Study
Started 23
Completed 19
Not Completed 4
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description

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.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
59
(44 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.
Hide Description Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are > 0 cm from the tumor edge.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description:

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: cm
1.7  (1.2)
2.Secondary Outcome
Title Positive Margin Rate
Hide Description The positive margin rate as defined by standard pathologic evaluation of the entire specimen.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description:

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage
0
3.Secondary Outcome
Title The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System
Hide Description Distances will be measured and descriptive statistics will be employed.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description:

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm
0.33  (0.32)
4.Secondary Outcome
Title Mean Resection Specimen Volume
Hide Description Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.
Time Frame 30 days from surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description:

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm3
116  (73)
Time Frame From the inception of baseline to end of intervention: 5 years
Adverse Event Reporting Description Regular investigator assessment and regular laboratory testing
 
Arm/Group Title Breast Cancer Locator (BCL)
Hide Arm/Group Description

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 the procedure.

Breast Cancer Locator (BCL): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the 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.

All-Cause Mortality
Breast Cancer Locator (BCL)
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Breast Cancer Locator (BCL)
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Breast Cancer Locator (BCL)
Affected / at Risk (%)
Total   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Richard J. Barth Jr.
Organization: Dartmouth Hitchcock Medical Center
Phone: (603) 650-9479
Responsible Party: Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02550210     History of Changes
Other Study ID Numbers: D15120
First Submitted: August 25, 2015
First Posted: September 15, 2015
Results First Submitted: April 8, 2019
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019