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In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. This approach of adopting palpable cancer patients before initiating an evaluative trial of the BCL in non-palpable breast cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care procedure.
The investigators propose to test whether the Breast Cancer Locator (BCL) accurately defines the edges of the tumor. Twenty patients with palpable invasive breast cancer will undergo preoperative supine MRI, the creation of a BCL, and breast-conserving surgery using the BCL as an adjunct to palpation-guided tumor resection. Participants will also have the tumor position on their skin localized with the supine MR/optical scan/tracker method. The primary objective is to measure the distance from the center of the spots made by the BCL to the cancer edges.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Locator (BCL) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer Locator (BCL) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. | 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. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Margin Rate | The positive margin rate as defined by standard pathologic evaluation of the entire specimen. | 30 Days |
| The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. | 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. | Posted | Mean | Standard Deviation | cm | 30 Days |
|
From the inception of baseline to end of intervention: 5 years
Regular investigator assessment and regular laboratory testing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard J. Barth Jr. | Dartmouth Hitchcock Medical Center | (603) 650-9479 | Richard.J.Barth.Jr@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2015 | Mar 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Distances will be measured and descriptive statistics will be employed. |
| 30 days |
| Mean Resection Specimen Volume | Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning. | 30 days from surgery |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Positive Margin Rate | The positive margin rate as defined by standard pathologic evaluation of the entire specimen. | Posted | Number | percentage | 30 Days |
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| Secondary | The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System | Distances will be measured and descriptive statistics will be employed. | Posted | Mean | Standard Deviation | cm | 30 days |
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| Secondary | Mean Resection Specimen Volume | Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning. | Posted | Mean | Standard Deviation | cm3 | 30 days from surgery |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D017437 |
| Skin and Connective Tissue Diseases |