Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection (BCD)
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|ClinicalTrials.gov Identifier: NCT02411760|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Procedure: 3 Tesla Magnetic Resonance Imaging|
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|
|Actual Enrollment :||60 participants|
|Official Title:||Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
- Procedure: 3 Tesla Magnetic Resonance Imaging
Assessment of the performance of DWI/ADC measurements alone, and as an adjunct to dynamic contrast enhanced (DCE) MRI in diagnosing/characterizing breast cancer.Other Names:
- Diffusion Weighted Imaging
- Dynamic Contrast Enhanced
- Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection. [ Time Frame: Each of 60 patients will have 1 60 minute scan prior to biopsy ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411760
|United States, Texas|
|UT Southwestern Medical Center - Advanced Imaging Research Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Robert Lenkinski, MD||UT Southwestern Medical Center|