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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Procedure: 3 Tesla Magnetic Resonance Imaging

Detailed Description

MR examinations will be performed on a 3.0 Tesla GE whole-body scanner using an elliptically driven body coil for transmit and a multi-channel bilateral breast coil for receive. The multi-channel coil will consist of 8, 16 or 31 channels. DCE-MRI: DCE-MRI will be carried out using a three-dimensional (3D) turbo fast lowangle gradient echo sequence (TFE) combined with parallel acquisition Sensitivity Encoding (SENSE) technique. The imaging plane will be set in axial plane so that both breasts are included in the images. One image will be acquired before and four images will be acquired after intravenous administration of a standard dose of 0.1 mmol per kg of body weight of Gadavist (Schering AG, Germany) at a rate of 3ml/sec. with subjects in the prone position, breathing normally during the scan. The total scan time for the DCEMRI will be about 8 minutes.

Pharmacokinetic parameters, including the volume transfer constant Ktrans, the fractional volume of extravascular extracellular space of the target tissue ve, and the rate constant kep, will be estimated by fitting a pharmacokinetic model to the time-intensity curves obtained from the DCE-MRI. In this study, the concentration of tracer Ct(t) after bolus injection is assumed to obey the model proposed by Tofts and Kermode (20). DWI-MRI examinations: The DWI acquisition will occur before and/or after contrast enhancement used in DCE imaging. Immediately after the completion of imaging with the 16 (or 31) channel breast coil, the patient will be repositioned replacing the breast coil with an 8 channel breast coil and additional DWI acquisitions will be made. Data for apparent diffusion coefficient assessment on diffusion-weighted imaging will be acquired using a single-shot Echo Planar Imaging sequence in the transverse plane. The DWI protocol will acquire images with up to 16 different b values. Slice dependent shimming will be performed to provide the maximum B0 homogeneity for each slice. The total scan time for the DWI-MRI will be about 5 minutes.

All of the DWI image data from the MRI examinations will be stored on a dedicated HIPPA compliant computer workstation (located in room NE6.114) for analysis. The relevant parameters will be mean ADC and the histogram of ADC in the lesions.

Conductivity imaging: A B1 map and a spin echo image will be acquired for measuring tissue conductivity (21).

The images used for conductivity measurement will be anonymized and sent to the manufacturer for further development of post-processing techniques.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center - Advanced Imaging Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Robert Lenkinski, MD, UT southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: MRI
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STU 052014-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED