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The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.
This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 women undergoing clinical breast MRI | At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols. |
| |
| 50 women undergoing clinical breast MRI | At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predictive Model | Diagnostic Test | Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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250 women scheduled for clinical breast MRI
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| Name | Affiliation | Role |
|---|---|---|
| Laura Heacock, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication
Requests may be directed to the PI
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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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| ID | Term |
|---|---|
| D000098412 | Predictive Learning Models |
| ID | Term |
|---|---|
| D000098411 | Prediction Methods, Machine |
| D001185 | Artificial Intelligence |
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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| Breast Imagers | Diagnostic Test | Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol. |
|
| D017437 |
| Skin and Connective Tissue Diseases |