Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection

Completed

Conditions studied: Breast Neoplasms

In brief

In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will be determined using pathology as the gold standard.

Key facts

Study ID: NCT02411760
Run by: University of Texas Southwestern Medical Center
People needed: 60
Starts: 2014-05-01
Expected to finish: 2017-05-01
Last updated by the study team: 2017-10-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.

You may not qualify if…

Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.
Contraindications to MRI examinations include:
Medically unstable
Heart failure
Unstable angina
Child bearing
Lactating Any contraindication per MRI Screening Form (Appendix A attached).
Implants contraindicated at 3T, pacemakers
Poorly controlled diabetes
Body weight greater than 300 pounds
Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:
eGFR < 60 mL/min/1.73m2
Sickle cell disease
Hemolytic anemia
Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.

Where it is running

UT Southwestern Medical Center - Advanced Imaging Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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