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

NCT02411760 | Completed

• 1 other identifier: STU 052014-042
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

• Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection.

  The sensitivity and specificity of breast cancer detection using ADC maps acquired with a 31 channel breast coil and improved B0 shimming will be compared to the sensitivity and specificity of cancer detection using DCE MRI.

  Each of 60 patients will have 1 60 minute scan prior to biopsy

Interventions

3 Tesla Magnetic Resonance Imaging PROCEDURE

Assessment of the performance of DWI/ADC measurements alone, and as an adjunct to dynamic contrast enhanced (DCE) MRI in diagnosing/characterizing breast cancer.

Also known as: Diffusion Weighted Imaging, Dynamic Contrast Enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the UTSW Breast Imaging Center referred for breast biopsy due to suspicious mammography or ultrasound exams (SOC) with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5.

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Lenkinski, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: April 8, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)