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| ID | Type | Description | Link |
|---|---|---|---|
| 08755 | Other Identifier | University of California, San Francisco | |
| NCI-2019-07528 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| R01CA116182 | U.S. NIH Grant/Contract | View source | |
| U01CA225427 | U.S. NIH Grant/Contract | View source | |
| R01CA249016 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY*
RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.
PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer patients | Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Procedure | Undergo MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality | Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI. | 1 month |
| Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS | Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI. | 1 month |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Patients at the University of California, San Francisco Breast Care Center meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Participants receiving care for breast cancer who also have a biopsy proven DCIS or ADH.
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| Name | Affiliation | Role |
|---|---|---|
| Nola M. Hylton, PhD | University of California, San Francisco | Principal Investigator |
| Bonnie Joe, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2023 | Jan 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C090600 | gadobutrol |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Gadavist | Drug | Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |