Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Prone to Supine MRI

Timothy B Rooney, MD

The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.

The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.

These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.

The Prone to Supine Breast MRI Trial

Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.

Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.

Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.

Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio

Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.

Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.

Dartmouth-Hitchcock Medical Center

The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Timothy B Rooney, MD, PI

Radiologist A, number of participants successfully segmented

Prone to Supine MRI Evaluated by Radiologist A

Radiologist B, number of participants successfully segmented

Prone to Supine MRI Evaluated by Radiologist B

Number of Successful Segmentation of Supine MRI Images

Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).

Prone Images

Supine Images

One participant was not able to complete both the Prone and Supine Imaging and was excluded.

Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor

Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.

Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary

The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.

Enhancement Quantification- Tumor-to-Background Ratio

Time to Position and Obtain Supine Images

Quantify the perceived comfort level of the prone MRI as reported by participants.

Overall Comfort - Prone Participants.

Quantify the perceived comfort level of the supine MRI as reported by participants.

Overall Comfort Participants - Supine

This assessment of overall perceived comfort was added to the study during the study period, and only the last 28 patients evaluated their overall comfort with the prone and supine portions of the examination.

Overall Comfort for Prone and Supine Positions

Overall Study

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.

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.

Breast Cancer Locator (BCL)

Richard J Barth, Jr., MD

The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.

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 surgeon can feel the cancer, 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, but are only 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, the investigators 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.

A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).

Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (tumor segregated accurately from supine MRI). The data is recorded by the radiologist on the CRF form.

Unit of measure is in days. Final measure will be average days to delivery among all patients. The data is recorded by the surgeon on the CRF form.

Yes/No answer from Surgeon. Final measure will be % of cases rated Yes (BCL enabled surgeon to successfully place all cues). The data is recorded by the surgeon on the CRF form.

Unit of measure is in mL, calculated by water displacement. Final measure will be average volume (mL) among all patients. The data is recorded by the study sponsor, Cairn Surgical, on the CRF form.

Unit of measure is in minutes. Final measure will be average operative time (min.) among all patients. Data is collected by the surgeon from operative notes and placed in the CRF form.

Unit of measure is in cm. Final measure will be average margin (in cm) among all patients. Data is collected by the surgeon from the pathology report and reported in the CRF form.

Surgeon to list any complications - which could include infections or bruising. Final measure will be % of patients with complications. Data is collected from the surgeon either post-operatively, if there were operative complications; or at the post-operative follow-up appointment with the patient, if she reports any complications then. It is also possible this data could be collected at any time between surgery and follow up appointment by the patient calling the surgeon's office to report it. The surgeon records this data in the CRF form.

Yes/No answer. Final measure will be % of surgeons who say Yes to satisfaction with the procedure. Data is collected from the surgeon and reported in the CRF form.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Prone to Supine Breast MRI Trial	NCT03573804	Breast Cancer	Prone to Supine...	18 Years -	Dartmouth-Hitchcock Medical Center
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers	NCT03573661	Palpable Breast...	Breast Cancer L...	18 Years -	Dartmouth-Hitchcock Medical Center
The Prone to Supine Breast MRI Trial	NCT03573804	Breast Cancer	Prone to Supine...	18 Years -	Dartmouth-Hitchcock Medical Center
The Prone to Supine Breast MRI Trial	NCT03573804	Breast Cancer	Prone to Supine...	18 Years -	Dartmouth-Hitchcock Medical Center
The Prone to Supine Breast MRI Trial	NCT03573804	Breast Cancer	Prone to Supine...	18 Years -	Dartmouth-Hitchcock Medical Center

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