Breast Cancer
Conditions
Keywords
Breast Cancer Locator
Brief summary
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.
Detailed description
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.
Interventions
OTHERProne 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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Female gender. * Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ * Tumor size at least 1 cm in diameter as visualized on mammogram or US. * A diagnostic breast MRI is considered to be clinically indicated. * Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
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 (eGFR \< 30 ml/min/1.73m2). * History of median sternotomy. * Pregnancy. Patient attestation that they are not pregnant will be acceptable. * Patients who have received neoadjuvant chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful Segmentation of Supine MRI Images | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor | 30 minutes | 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. |
| Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary | 30 minutes | Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging. |
| Enhancement Quantification- Tumor-to-Background Ratio | 30 minutes | 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 |
| Time to Position and Obtain Supine Images | 30 Minutes | 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. |
| Overall Comfort for Prone and Supine Positions | Within 15 minutes of the scan | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | claustrophobia or MRI table problems | 10 |
Baseline characteristics
| Characteristic | Prone to Supine MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| 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 | 1 Participants |
| Race (NIH/OMB) White | 71 Participants |
| Region of Enrollment United States | 72 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Number of Successful Segmentation of Supine MRI Images
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.
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Number of Successful Segmentation of Supine MRI Images | 54 Participants |
| Prone to Supine MRI Evaluated by Radiologist B | Number of Successful Segmentation of Supine MRI Images | 61 Participants |
Secondary
Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor
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.
Time frame: 30 minutes
Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor | 370.09 Tesla per second |
| Prone to Supine MRI Evaluated by Radiologist B | Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor | 594.77 Tesla per second |
Comparison: 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).p-value: <0.00195% CI: [90.26044, 359.08956]t-test, 2 sided
Secondary
Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary
Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.
Time frame: 30 minutes
Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary | 217.96 Tesla per second |
| Prone to Supine MRI Evaluated by Radiologist B | Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary | 383.80 Tesla per second |
Comparison: 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.p-value: <0.00195% CI: [78.34708, 253.31892]t-test, 2 sided
Secondary
Enhancement Quantification- Tumor-to-Background Ratio
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
Time frame: 30 minutes
Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Enhancement Quantification- Tumor-to-Background Ratio | 1.74 Ratio |
| Prone to Supine MRI Evaluated by Radiologist B | Enhancement Quantification- Tumor-to-Background Ratio | 1.62 Ratio |
Comparison: 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.p-value: 0.005895% CI: [-0.04209, 0.28209]t-test, 2 sided
Secondary
Overall Comfort for Prone and Supine Positions
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.
Time frame: Within 15 minutes of the scan
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Overall Comfort for Prone and Supine Positions | 1.82 units on a scale |
| Prone to Supine MRI Evaluated by Radiologist B | Overall Comfort for Prone and Supine Positions | 0.61 units on a scale |
p-value: 0.00049664Students two-tailed paired t-test
Secondary
Time to Position and Obtain Supine Images
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.
Time frame: 30 Minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prone to Supine MRI Evaluated by Radiologist A | Time to Position and Obtain Supine Images | 7.25 minutes |