High Resolution 3D Diffusion-weighted Breast MRI
Recruitment status was Recruiting
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Purpose
The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.
| Condition | Intervention |
|---|---|
|
Breast Cancer Carcinoma Breast Stage IV |
Device: Magnetic Resonance Image Scanner |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | High Resolution 3D Diffusion-weighted Breast MRI |
- Sensitivity of the new MRI method [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Lesion detection rate of the new MRI method [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
-
Device: Magnetic Resonance Image Scanner
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Stanford Radiology Department MRI facilities
Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.
2. Female
3. Age >18
Exclusion Criteria:1. Lactation
2. Pregnancy
3. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.
4. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.
Contacts and Locations| Contact: Alice Gardner | (650) 725-1812 | agardner@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Alice Gardner 650-725-1812 agardner@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Bruce Lewis Daniel | |
| Sub-Investigator: Brian Andrew Hargreaves | |
| Principal Investigator: | Bruce Lewis Daniel | Stanford University |
More Information
No publications provided
| Responsible Party: | Bruce Lewis Daniel, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01315106 History of Changes |
| Other Study ID Numbers: | SU-11152010-7211, BRS0013 |
| Study First Received: | March 11, 2011 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013