Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Any patient undergoing MRI guided preoperative needle localization or MRI guided biopsy of the breast.

With an IV catheter in place, the patient will lie prone on the MRI scanner table with the breasts positioned in the commercial breast coil and then be moved feet first to the center of the MRI scanner. The only difference introduced by the addition of DCE MRI is that before the patient is moved into the scanner for the first time, the IV catheter will be hooked up with a programmable power injector (Medrad, Indianola, PA) which is loaded with Gd contrast and saline. The contrast injection and saline flush will be delivered by the injector while the patient is inside the scanner and the DCE MRI data collection is in process. The Gd contrast dose used for DCE MRI is the same as for clinical MRI: 0.1 mmol/kg. The injection speed of 2 mL/sec is safe and similar to that of manual injection.

perform dynamic contrast enhanced (DCE) MRI

Sunitha Thakur, PhD

The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.

Our aim is to perform dynamic contrast enhanced (DCE) MRI on 150 patients during their routine breast MRI examination at MSKCC. This will add extra 10 min scanning time to the routine examination. High resolution (submillimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the DCE MRI data. These results will be correlated with pathology to determine new pharmacokinetic threshold so that the negative predictive value for benign lesions is close to 100%. The improvement in diagnostic specificity may help to reduce unnecessary biopsies in the future.

Quantitative Dynamic Contrast Enhanced Breast MRI

Oregon Health and Science University

DeltaPoint,Inc.

Memorial Sloan Kettering Cancer Center

Breast Diseases

Skin Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification

Siemens Medical Solutions USA, Inc. (Mountain View, CA) has implemented Virtual Touch Tissue Imaging Quantification (VTIQ) technology on a commercially available general purpose US imaging system (trade name: Acuson S2000 or S3000). This system has received clearance under Food and Drug Administration (FDA) 510(k) number K072786 (S3000) and K130881 (VTIQ). The technology uses a set of tailored US pulses (Acoustic Radiation Force Impulse, ARFI) to induce shear waves in breast tissue due to tissue displacement. A set of standard B-mode pulses detect the perpendicular shear waves. The displacement signals can be processed using algorithms on a Virtual Touch IQ-equipped system in order to calculate the shear wave velocity.

Ultrasound- Virtual Touch Tissue Imaging Quantification

Michael Golatta, PD Dr. med., MHBA

The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).

Elastography is a method of imaging tissue stiffness. It is based on shear wave velocity information that can be mapped to create an image of the stiffness in the region of interest.

Sonoelastography is used to differentiate benign from malignant lesions since malignant lesions alter tissue elasticity.

Adding Shear Wave elastographic features to BI-RADS® feature analysis- especially in lesions scored BI-RADS® 3 and 4a- improved specificity of breast US mass assessment without loss of sensitivity.

The BI-RADS® categories are defined by the risk for a malignant lesion varying from benign BI-RADS® 2 lesions, up to a 2% malignancy rate in BI-RADS® 3 and 2- 95% in BI-RADS® 4 (4a 2-10%; 4b 10-50%; 4c 50-95%). Based on these probabilities, biopsies are recommended for BI-RADS® 4 and 5 lesions and short-term follow-up examinations for BI-RADS® 3. Consequently, up to 2% of the in Ultrasound visible breast cancers are not directly detected as such and put into the BI-RADS® 3 category. In contrast, in the BI-RADS® 4a category more than 90% of the biopsies are unnecessary.

The main aim of the confirmatory study is to use Virtual Touch Tissue Imaging Quantification in order to reduce unnecessary benign biopsies without a reduction of the number of detected cancers.

This multi-center study is planned to involve 12 sites in 7 countries. Recruitment started at the first sites in February 2016. Recruitment takes place in the course of the patient's routine visit at a certified breast unit. All study participants will receive VTIQ in addition to standard ultrasound.

Enrollment goal is a total of 1000 cases, split into groups of a minimum of n= 300 BI-RADS® 3, n= 400 BI-RADS® 4a, n= 100 BI-RADS® 4b, n= 100 BI-RADS® 4c. All patients will be documented in a screening list. Monitoring will be performed by the Coordination Center for Clinical Trials (KKS Heidelberg). Completeness, validity and plausibility of data will be checked in time of data entry (edit-checks) and using validating programs, which will generate queries. The investigator or the designated representatives are obliged to clarify or explain the queries. If no further corrections are to be made in the database it will be closed and used for statistical analysis. All data management procedures will be carried out on validated systems and according to the current Standard Operating Procedures (SOPs) of the Institute of Medical Biometry and Informatics.

The standard BI-RADS® Ultrasound (US) category (BI-RADS® 3-4c) and VTIQ values will be correlated with the histological result. Additionally, local (BI-RADS® given at each site) and central expert BI-RADS® assessment will be compared (BI-RADS® assessment and assessment of the variables leading to the BI-RADS® value separately) to assess the inter-rater reliability. In addition, the BI-RADS® assessments will be compared with the histological results.

The variable "measurement lesion (in m/s)" is derived from three VTIQ measurements as follows:

I. For confirmatory analysis of primary objectives an algorithm was established,

1. using the first measurement for analysis if the value is smaller than 2.5 m/s or if the value is larger than 4.5 m/s. If the first measurement is smaller than 2.5 m/s, the lesion can be considered benign and no further diagnostics is needed. If the lesion is larger than 4.5 m/s the lesion should be considered suspicious and further diagnostics is required.
2. requiring two additional measurements (in total three measurements) if the first measurement is in the range of ≥ 2.5 m/s to ≤ 4.5 m/s. In this case the average of all three measurements is used for analysis.

II. For descriptive analysis other options for derivation of this variable from the three VTIQ measurements will be calculated for discussion:

1. First measurement only
2. Average of all three measurements
3. Median of all three measurements
4. Maximum of all three measurements

In conjunction with the maximum VTIQ shear wave velocity the quality display will be used to aid in the classification of lesions as malignant or benign as follows:

1. If the shear wave velocity ≥ the cut-off value (3.5 m/s), the lesion is considered potentially malignant, regardless of the outcome of the quality factor
2. If a lesion or lesion rim has a completely high quality factor (all green) and a shear wave velocity \< the cut-off value (3.5 m/s), the lesion is considered benign.
3. If a lesion or lesion rim has mixed high and low quality factors (there are areas with low quality within the mass) and the only area of high quality (green) has a shear wave velocity \< the cut-off value (3.5 m/s), then the lesion is indeterminate and malignancy cannot be excluded.

Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions

Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions: Can Patient Selection for Biopsy be Improved? - A Confirmatory Multi-Center-Study

Hierarchical testing of the main statistical hypotheses H0_1, H0_2, H0_3 (test for H0_1 defines a gatekeeper) to evaluate the diagnostic accuracy of VTIQ in the differentiation of BI-RADS® 3 and 4a lesions:

H0_1: The proportion of malignancies for group A (BI-RADS 4a, VTIQ ≥ cut-off) is less or equal to the proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off).

versus

H1_1: The proportion of malignancies for group A is higher than the proportion of malignancies for group B.

H0_2: The proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off) is larger than or equal to 2%.

versus

H1_2: The proportion of malignancies for group B is smaller than 2%.

H0_3: The proportion of malignancies for group D (BI-RADS 3, VTIQ \< cut-off) is larger than or equal to 2%.

versus

H1_3: The proportion of malignancies for group D is smaller than 2%.

Equivalent hypotheses as given for primary outcome measures can be formulated for the patients finally staged as BI-RADS® 3, 4b and 4c. These hypotheses will be analyzed with corresponding chi-square tests, where the resulting p-values are only interpreted descriptively:

To assess whether ultrasonically visualized breast lesions, categorized as BI-RADS® 3/ 4b/ 4c with a VTIQ-measured shear velocity value of smaller than 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 3/ 4b/ 4c with a VTIQ-measured shear velocity value of larger than or equal to 3.5 m/s (37 kPa).

Two logistic regression models including including BI-RADS® or BI-RADS® and VTIQ will be compared to test whether the probabilities for malignancies predicted with ultrasonically visualized breast lesions categorized as BI-RADS® differ from the probabilities for malignancies predicted with ultrasonically visualized breast lesions categorized as BI-RADS® and VTIQ-measured shear velocity.

Equivalent hypotheses as given in H0_1 vs H1_1 can be formulated for the patients initially staged as BI-RADS® 3, 4b and 4c. These hypotheses will be analyzed with corresponding chi-square tests, where the resulting p-values are only interpreted descriptively to test whether for women with ultrasonically visualized breast lesions categorized as BI-RADS® 3, 4a, 4b or 4c respectively, the subgroup of women with a strain ratio smaller than or equal to 1 shows a lower malignancy rate than the subgroup of women with a strain ratio of larger than 1.

Robust regression models (Passing-Bablok-regression, orthogonal regression) and Bland-Altman Plots will be used for pairwise comparison of the continuous values between raters, where a slope of 1 and an intercept of 0 indicates agreement.

Thereby the following factors will be examined:

Subject-related factors:

* Skin - breast lesion surface depth (cm)
* Quality factor (color coded scale) within the lesion
* Breast density/ Tissue composition (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture)
* Lesion size in B-mode (cm)
* Normal fatty tissue shear wave velocity (Ratio between measurement in the fatty tissue and in the lesion)
* Pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others)
* Grading (G1, G2, G3, Gx)
* Immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%))

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the skin - breast lesion surface depth (cm).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the Quality factor (color coded scale) within the lesion.

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the breast density/ tissue composition (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the lesion size in B-mode (cm).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the normal fatty tissue shear wave velocity (ratio between measurement in the fatty tissue and in the lesion).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the grading (G1, G2, G3, Gx).

For descriptive analysis of predictive factors of the continuous VTIQ-value, different univariable und multivariable linear regression models will be evaluated and compared.

Thereby one factor to be examined is the immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%)).

Local (BI-RADS® given at each site) and central expert BI-RADS® assessment will be compared (BI-RADS® assessment and assessment of the variables leading to the BI-RADS® value separately).

To test the inter-rater reliability of BI-RADS® Assessment Cohens' Kappa will be calculated.

Local (BI-RADS® given at each site) and central expert BI-RADS® assessment will be compared (BI-RADS® assessment and assessment of the variables leading to the BI-RADS® value separately). To test the inter-rater reliability of BI-RADS® Assessment ICC values will be calculated.

To compare the BI-RADS® assessments with the histological results, the malignancy rates will be computed separately for each BI-RADS® value. It will then be checked whether these rates lie within the given intervals. Furthermore, the likelihood of malignancy estimated by the experts will be examined using receiver operating curve (ROC) and area under the curve (AUC).

We will increase the cut-off value step-by-step by a small amount and repeat the primary analysis (using a chi-square test). We stop the testing procedure as soon as the p-value is above the significance level (0.05). This analysis is, obviously, only an explorative one and has no confirmatory value.

Siemens Medical Solutions

Heidelberg University

PD Dr. med.

Papilloma

Fibroadenoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Margaret Chen, MD

The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.

ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.

American Breast Laser Ablation Therapy Evaluation

American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantitative Dynamic Contrast Enhanced Breast MRI	NCT00582764	Breast Cancer	perform dynamic...	-	Memorial Sloan Kettering Cancer Center
Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions	NCT02638935	Breast Neoplasm...	Ultrasound- Vir...	18 Years -	Heidelberg University
Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions	NCT02638935	Breast Neoplasm...	Ultrasound- Vir...	18 Years -	Heidelberg University
American Breast Laser Ablation Therapy Evaluation	NCT00807924	Benign Breast C...		18 Years -	Novian Health Inc.
Quantitative Dynamic Contrast Enhanced Breast MRI	NCT00582764	Breast Cancer	perform dynamic...	-	Memorial Sloan Kettering Cancer Center

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