Breast Cancer
Conditions
Keywords
Breast Conserving Surgery, Breast Imaging, Breast Diagnostics
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ * Patient desire to undergo breast surgery * Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted * The cancer enhances on breast MRI imaging.
Exclusion criteria
* Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia * Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine \> 2.0) * History of median sternotomy * Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. | 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Margin Rate | 30 Days | The positive margin rate as defined by standard pathologic evaluation of the entire specimen. |
| The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System | 30 days | Distances will be measured and descriptive statistics will be employed. |
| Mean Resection Specimen Volume | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Breast Cancer Locator (BCL) |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
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.
Time frame: 30 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Locator (BCL) | 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
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.
Time frame: 30 days from surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Locator (BCL) | Mean Resection Specimen Volume | 116 cm3 | Standard Deviation 73 |
Secondary
Positive Margin Rate
The positive margin rate as defined by standard pathologic evaluation of the entire specimen.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast Cancer Locator (BCL) | Positive Margin Rate | 0 percentage |
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.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Locator (BCL) | 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 |