High Resolution 3D Diffusion-weighted Breast MRI

Trial Title: High Resolution 3D Diffusion-weighted Breast MRI

NCT ID: NCT01315106

Condition: Breast Cancer
Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Magnetic Resonance Image Scanner
Description: Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner

Other name: MRI

Summary: The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.

Detailed description: 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.

Criteria for eligibility:

Study pop:
Stanford Radiology Department MRI facilities

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Stanford University School of Medicine

Address:
City: Stanford
Zip: 94305
Country: United States

Start date: March 2011

Completion date: February 2025

Lead sponsor:
Agency: Stanford University
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Source: Stanford University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01315106