High Resolution 3D Diffusion-weighted Breast MRI

Breast Cancer Clinical Trial

Official title:

High Resolution 3D Diffusion-weighted Breast MRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01315106
• Other study ID #: IRB-19595
• Secondary ID: SU-11152010-7211
• Status: Active, not recruiting
• Start date: March 2011
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Device:
• Magnetic Resonance Image Scanner
Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the new MRI method		8 weeks
Primary	Lesion detection rate of the new MRI method		4 weeks