Trial Outcomes & Findings for A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers (NCT NCT02550210)

Last Updated: 2019-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

30 Days

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	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 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 Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Cancer Locator (BCL) n=23 Participants 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.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Outcome measures
Measure	Breast Cancer Locator (BCL) n=18 Participants 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.
The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.	1.7 cm Standard Deviation 1.2

SECONDARY outcome

Timeframe: 30 Days

The positive margin rate as defined by standard pathologic evaluation of the entire specimen.

Outcome measures

Outcome measures
Measure	Breast Cancer Locator (BCL) n=19 Participants 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.
Positive Margin Rate	0 percentage

SECONDARY outcome

Timeframe: 30 days

Distances will be measured and descriptive statistics will be employed.

Outcome measures

Outcome measures
Measure	Breast Cancer Locator (BCL) n=19 Participants 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.
The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System	0.33 cm Standard Deviation 0.32

SECONDARY outcome

Timeframe: 30 days from surgery

Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.

Outcome measures

Outcome measures
Measure	Breast Cancer Locator (BCL) n=19 Participants 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.
Mean Resection Specimen Volume	116 cm3 Standard Deviation 73

Adverse Events

Breast Cancer Locator (BCL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard J. Barth Jr.

Dartmouth Hitchcock Medical Center

Phone: (603) 650-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place