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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03481 | Other Identifier | NCI |
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This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed.
In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Our secondary objectives will be to determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 addition of supine MRI to conventional imaging | Active Comparator | Arm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery. |
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| Arm 2 randomize to SOC vs supine MRI + SOC | Active Comparator | Arm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine MRI | Device | A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. | Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI. | From baseline MRI to intraoperative measurements: 30 days |
| To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery. | The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria. | 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences Between the Two Groups in the Volume of Breast Tissue Removed | The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis. | 30 days from surgery |
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Inclusion Criteria Phase 1
3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.
Inclusion Criteria Phase 2
Exclusion Criteria (Phases 1 and 2)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
No participants from Phase 1 participated in Phase 2
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Addition of Supine MRI to Conventional Imaging | Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI) |
| FG001 | Phase 2: Addition of Supine MRI to Conventional Imaging | Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI) |
| FG002 | Phase 2: Conventional Imaging (SOC) | Wire localized (group WL) partial mastectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Addition of Supine MRI to Conventional Imaging | Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI) |
| BG001 | Phase 2: Addition of Supine MRI to Conventional Imaging |
| 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, Customized | Count of Participants |
| 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 Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. | Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI. | Posted | Mean | Full Range | mm | From baseline MRI to intraoperative measurements: 30 days |
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From the inception of Phase 1 (baseline) to end of intervention for Phase 2: 7 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 | Phase 1: Addition of Supine MRI to Conventional Imaging | Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
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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 | May 6, 2014 | 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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| Screen Fail |
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Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)
| BG002 | Phase 2: Conventional Imaging (SOC) | Wire localized (group WL) partial mastectomy |
| BG003 | Total | Total of all reporting groups |
| Participants |
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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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| Primary | To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery. | The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria. | Posted | Count of Participants | Participants | 30 days from surgery |
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| Secondary | Differences Between the Two Groups in the Volume of Breast Tissue Removed | The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis. | Posted | Mean | Standard Deviation | ml | 30 days from surgery |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Phase 2: Addition of Supine MRI to Conventional Imaging | Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI) | 0 | 69 | 1 | 69 | 0 | 69 |
| EG002 | Phase 2: Conventional Imaging (SOC) | Wire localized (group WL) partial mastectomy | 0 | 69 | 1 | 69 | 0 | 69 |
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| D017437 |
| Skin and Connective Tissue Diseases |