Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Healthy women presenting to enrollment sites for routine annual mammographic examinations, confirmed to have BI-RADS category c or d breast composition (density).

Routine screening mammography exam, CC + MLO views.

Routine Full-Field Digital Mammography

Routine screening tomosynthesis exam, CC + MLO views.

Routine Digital Breast Tomosynthesis

Bilateral breast ultrasound performed as an adjunct to mammography.

Automated Whole Breast Ultrasound

Mary W Yamashita, MD

The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography.

SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device.

This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801.

Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data.

The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.

MEDICAL DEVICES:

* SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies.
* SoftVue™ with device modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
* Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers.
* Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.

OBJECTIVES:

* Primary: To establish a library of cases for use in future SoftVue™ research studies, user training, and marketing.
* Secondary: Determine the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue.

ENDPOINTS:

From multiple clinical sites whichever comes first:

* Up to 17,500 total enrolled subjects
* Up to 105 total breast cancer cases detected at program entry screening
* At least 35 total discordant breast cancer cases, where FFDM is negative or benign (BI-RADS 1 or 2) but SV is incomplete (BIRADS 0) and diagnostic imaging workup of SV findings leads to breast biopsy with malignant pathology

SITES:

At least six (≥ 6) qualified clinical sites in the United States

* MQSA Certified
* Digital Breast Tomosynthesis Screening Program Implemented
* Academic, Community Hospital, or Private Practice Setting

PROJECT DESIGN AND PROCEDURES:

* Potential participants will be recruited from the group of women presenting for their annual breast imaging exams at multiple clinical sites utilizing 3D DBT and 2D FFDM (non-synthesized) for routine screening.
* Asymptomatic women with heterogeneously or extremely dense breast parenchyma (BI-RADS composition c or d), based on visual assessment of FFDM by trained site personnel, will be invited to consider volunteering to participate in the case collection program.
* All participants will complete the same routine screening FFDM + DBT evaluation for which they originally reported to the clinic, with a complete set of 2D views and 3D views.
* Eligible patients will receive SV as an adjunct to FFDM + DBT.
* A single Investigator (radiologist) at each site will perform sequential review of the same subjects FFDM, DBT, and SV images.
* FFDM will be evaluated for final parenchymal density (BI-RADS a through d) and then each exam will be assigned to one of 3 BI-RADS assessment categories (0, 1, 2) by the radiologist.
* Abnormal findings will be indicated by a BI-RADS assessment category of 0 (Incomplete)and will undergo diagnostic imaging evaluations consistent with universally accepted standards of care.
* All evaluation results, diagnosis and treatment outcomes will be recorded.
* Normal findings will be indicated by BI-RADS assessment categories of 1 or 2 (Negative or Benign) which will be associated with a management recommendation to resume routine screening in one year, unless symptoms or signs of breast cancer develop in the interim.
* All participants who are not diagnosed with breast cancer as a direct result of the program entry examinations, incidental evaluations, or interval symptoms, will return to the site in 12 months for their next annual screening exam, the results and outcome of which will be recorded.
* Cancer status for all participants will be surveyed from program entry until and including the completion of recommended follow-up.
* A case will be determined cancer negative if the participant has no findings suspicious for cancer throughout the interval between program entry and completion of annual follow-up.
* A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis during the interval between program entry and completion of annual follow-up.

STATISTICAL ANALYSIS:

* Demographic characteristics (age, race, and ethnicity) and other baseline characteristics (e.g., project arm, project site, breast density, lesion-specific characteristics) will be tabulated for all participants.
* A flow diagram or table will illustrate patient disposition ("accountability of patient cohort") including reasons for ineligibility and/or unevaluability.
* Safety will be summarized for all enrolled women. With the exception of anticipated events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam, will be recorded.
* A separate statistical plan will be developed for any future analysis that includes justification of sample size and, if applicable to the requirements of FDAAA 801, will be registered separately in order to share the results.

Delphinus SoftVue Prospective Case Collection - ARM 1

ARM 1: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.

Non-Cancer cases, confirmed by normal or negative mammographic breast imaging (FFDM or DBT), or breast biopsy with benign pathology, after at least 365 days of follow-up

Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up

Delphinus Medical Technologies, Inc.

Non-Interventional: Women presenting to enrollment sites for diagnostic examinations of symptoms or imaging findings, as recommended by a physician, and assigned BI-RADS category 4 or 5 (biopsy indicated).

Only standard care procedures will be performed for clinical intervention and diagnostic purposes.

Non-Interventional

Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.

The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography.

SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device.

This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000 women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly limited to case collection and is non-interventional; any investigational and/or statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801.

Arm 2 is limited to the cohort of diagnostic female patients of any breast density composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic imaging and SV exams, from the same patient, demographic information, and clinical outcome data, will be collected during diagnostic workup. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected as well as objective and subjective breast density composition data. Ultrasound image data may be acquired with modified SoftVue devices, which have passed safety and quality evaluations per Delphinus' quality management system (QMS) and satisfy design change control standards, at select clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility, validation, and verification testing for engineering and product development purposes.

The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curricula, building teaching case, and creating new marketing materials for SoftVue.

MEDICAL DEVICES:

* SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies.
* SoftVue™ with device modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
* Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers. (If clinically indicated)
* Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.
* Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various manufacturers. (If clinically indicated)
* Other diagnostic tests and medical device examinations of the breast, including, but not limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed physician, when clinically indicated.

OBJECTIVES:

* Primary: To establish a library of cases for use in future SoftVue™ research studies, user training, and marketing.
* Secondary: Determine the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue.

ENDPOINTS:

From multiple clinical sites whichever comes first:

• Up to 1,000 total enrolled subjects

SITES:

At least six (≥ 6) qualified clinical sites in the United States

* MQSA Certified
* Digital Breast Tomosynthesis Screening Program Implemented
* Academic, Community Hospital, or Private Practice Setting

PROJECT DESIGN AND PROCEDURES:

* Potential participants will be recruited from the group of women presenting for diagnostic evaluation or biopsy at multiple clinical sites.
* All participants will complete the same standard care diagnostic evaluations that were recommended by a physician
* Eligible patients will receive a SV scan at the time of their scheduled diagnostic appointments, preferably prior to biopsy
* Investigators at the sites will compare SV images to the accompanying diagnostic images and pathology results
* No clinical SV interpretation will be performed and no clinical interventions will be made or changed based on SV images
* All evaluation results, diagnosis and treatment outcomes will be recorded
* Cancer status for all participants will be surveyed from program entry until and including the completion of physician recommended diagnostic workup
* A case will be determined cancer negative if the participant has non-malignant breast biopsy findings or confirmed non-suspicious diagnostic breast imaging findings
* A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis (malignancy)

STATISTICAL ANALYSIS:

* Demographic characteristics (age, race, and ethnicity) and other baseline characteristics (e.g., project arm, project site, breast density, lesion-specific characteristics) will be tabulated for all participants.
* A flow diagram or table will illustrate patient disposition ("accountability of patient cohort") including reasons for ineligibility and/or unevaluability.
* Safety will be summarized for all enrolled women. With the exception of anticipated events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam, will be recorded.
* A separate statistical plan will be developed for any future analysis that includes justification of sample size and, if applicable to the requirements of FDAAA 801, will be registered separately in order to share the results.

Delphinus SoftVue Prospective Case Collection - ARM 2

ARM 2: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.

Non-Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.

Cancer cases, confirmed by breast biopsy with malignant pathology

To compare the overall sensitivity and specificity of ABUS versus MRI (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients.

To compare the sensitivity and specificity of ABUS versus mammography (and hand-held breast ultrasound when clinically indicated) for the ipsilateral and contralateral breast in newly diagnosed breast cancer patients when MRI is not performed.

ABUS

Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.

This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.

Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients

Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients

Rate of detection of occult breast cancer by ABUS, otherwise missed by standard imaging (MRI or mammogram with hand-held breast ultrasound as clinically indicated).

University of Kansas Medical Center

Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.

Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.

Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.

Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.

A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.

CESM

ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.

ABB-MRI

Fiona Gilbert

Jaimie Taylor

Reena Aggarwal

Jonathan James

Sarah Vinnicombe

Sarah Savaridas

Archana Seth

Nisha Sharma

Tamara Suaris

William Teh

Anthony Maxwell

BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CESM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Breast Screening - Risk Adaptive Imaging for Density

All cancers (detected or interval) in each arm over a three year period will be collected.

size, lymph node status, metastatic status

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at prevalent round

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at incident round; Interval cancer rate; Stage of interval cancers; Size of interval cancers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Delphinus SoftVue Prospective Case Collection - ARM 1	NCT03257839	Breast Neoplasm...	Routine Full-Fi... Routine Digital... Automated Whole...	18 Years -	Delphinus Medical Technologies, Inc.
Delphinus SoftVue Prospective Case Collection - ARM 2	NCT02977247	Breast Neoplasm...	Non-Interventio... Automated Whole...	18 Years -	Delphinus Medical Technologies, Inc.
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients	NCT02488187	Breast Cancer	ABUS	18 Years -	University of Kansas Medical Center
Breast Screening - Risk Adaptive Imaging for Density	NCT04097366	Breast Cancer	ABUS CESM ABB-MRI	50 Years - 70 Years	University of Cambridge
Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients	NCT02488187	Breast Cancer	ABUS	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for abus

Every month we try and update this database with for abus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abus

Every month we try and update this database with for abus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.