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| Name | Class |
|---|---|
| CairnSurgical, Inc. | INDUSTRY |
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The purpose of this study is to determine whether a supine breast MRI obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast MRI will provide sufficient tumor visualization to allow a Radiologist to define and outline the tumor edges ("segment" the tumor). Accurate segmentation will allow a 3-D image of the tumor to be generated to create a breast cancer locator (BCL) surgical device to in aid removal of breast cancers.
The clinical pre-operative breast MRI exam will be obtained in the prone position with intravenous (IV) Gadolinium (Gd) contrast injection per standard of care clinical protocol. After completion of the standard clinical prone breast MRI, the participant will be re-positioned and the investigative supine breast MRI protocol with a second dose of IV Gd will be obtained. A second dose of contrast equal to the first dose will be given, and additional images will be obtained in the supine position. Subtraction images will be generated for both the prone and the supine sequences. It is hypothesized that the second contrast injection will generate tumor-to-fibroglandular contrast differences such that supine subtraction images will allow visualization and segmentation of the tumor equal to prone segmentation images. It is expected that the addition of a second injection of contrast will improve the ability to visualize and accurately segment the supine post-Gd images. While the total dose of gadolinium delivered in two injections is twice the amount normally given during a clinical prone breast MRI, this total dose is equal to that administered for other clinical MRI studies such as cardiac MRI.
No additional imaging or testing will be required for this research study following the standard clinical MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine MRI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine MRI | Procedure | After completion of the standard prone MRI sequences the patient will be positioned supine, coils will be placed and baseline images will be obtained. Then a second dose of contrast equal to the first dose will be given, and additional images will be obtained |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean tumor-to-fibroglandular contrast ratio in prone compared to supine breast MRI | Determine the mean tumor-to-fibroglandular contrast in a two bolus intravenous contrast injection prone to supine breast MRI study and compare this to the mean tumor-to-fibroglandular contrast of a single-contrast injection prone to supine breast MRI study. | Day of standard clinical MRI, 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate tumor visualization and segmentability on supine breast MRI exam with additional contrast injection obtained immediately after prone contrast breast MRI, and compare to tumor visualization and segmentability on clinical prone breast MRI. | Compare the proportion of cases with successful agreement between radiologists' segmentation volumes in the double-contrast dose prone to supine MRI study to proportion of cases with successful agreement in the single-contrast dose prone to supine MRI using a Hausdorff Distance (HD) threshold < 1 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate time required for double contrast prone to supine exam compared to single contrast prone to supine exam. | Determine the time required to obtain the double contrast prone to supine exam by recording start and stop times of both Supine and Prone MRI, using minutes and seconds. Compare exam time to single contrast prone to supine (prior study) | Day of MRI, 1 day |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Roberta diFlorio-Alexander, MD | DHMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 05055 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 17, 2024 | |
| Reset | Dec 2, 2024 | |
| Release | Feb 5, 2026 | |
| Reset | Feb 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 17, 2024 | Dec 2, 2024 | |||
| Feb 5, 2026 |
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| Day of MRI, 1 day |
| Feb 23, 2026 |