Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
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|ClinicalTrials.gov Identifier: NCT00804128|
Recruitment Status : Recruiting
First Posted : December 8, 2008
Last Update Posted : May 4, 2021
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: contrast-enhanced magnetic resonance imaging Drug: Gadavist|
- Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio).
- Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)|
|Actual Study Start Date :||October 1, 2008|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
- Procedure: contrast-enhanced magnetic resonance imaging
- Drug: Gadavist
Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imagingOther Name: Gadobutrol
- Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality [ Time Frame: 1 month ]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.
- Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804128
|Contact: Nola Hylton, PhDemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Margarita Watkins 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Nola Hylton, PhD|
|Principal Investigator:||Nola M. Hylton, PhD||University of California, San Francisco|
|Principal Investigator:||Bonnie Joe, MD, PhD||University of California, San Francisco|