Clinical trials: Dense Breast Density
Breast Diseases, Artificial Intelligence
Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics
It is a prospective, observational cohort study of patients with dense breast tissue. The study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast…
- Conditions
- Breast Diseases, Artificial Intelligence, Dense Breast Density, Predictive Cancer Model
- Trial name
- NCT04535466
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT
The purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.
- Trial name
- DBTUST (NCT02643966)
- Testing
- Whole breast ultrasound
- Where
- 2 sites in United States
- Volunteers
- 6,266 people, healthy volunteers welcome
- Sponsor
- Wendie Berg
Breast Neoplasms
Delphinus SoftVue Prospective Case Collection - ARM 1
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…
- Trial name
- SV PCC ARM1 (NCT03257839)
- Testing
- Routine Full-Field Digital Mammography, Routine Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound
- Where
- 10 sites in United States
- Volunteers
- 7,409 people, healthy volunteers welcome
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer
A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.
Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together…
- Trial name
- somo•InSIGHT (NCT00816530)
- Testing
- Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography
- Where
- 11 sites in United States
- Volunteers
- 15,679 people
- Sponsor
- U-Systems, Inc.
Breast Carcinoma
Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat.
- Trial name
- NCT03220893
- Testing
- Digital Breast Tomosynthesis (DBT), Scintimammography
- Where
- 5 sites in United States
- Volunteers
- 3,023 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Dense Breasts, Breast Cancer
Histology of Functional Density in Postmenopausal Breast
Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear.
- Trial name
- NCT01240278
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Cancer Screening, Breast Cancer Screening and Diagnosis
Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis
This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena".
- Trial name
- SINATRA (NCT07415499)
- Testing
- No intervention is administered.
- Where
- Italy
- Volunteers
- 3,300 people
- Sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
Breast Cancer
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening…
- Trial name
- NCT01424956
- Testing
- Automated Breast Ultrasound (ABUS)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- U-Systems, Inc.
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer, Early Detection of Cancer
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
- Trial name
- NCT04688086
- Testing
- Thermalytix
- Where
- India
- Volunteers
- 687 people, healthy volunteers welcome
- Sponsor
- Niramai Health Analytix Private Limited
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts
The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this…
- Trial name
- NCT05787249
- Testing
- Patient nudge, Provider nudge
- Where
- United States
- Volunteers
- 1,358 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer Prevention, Mammographic Density
RANKL Inhibition and Breast Tissue Biomarkers
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be…
- Trial name
- NCT03629717
- Testing
- Ultrasound-guided core needle biopsy, Denosumab, Blood draw
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Breast Neoplasms, Breast Density
DLSCT for Breast Cancer Detection in Women With Dense Breasts
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
- Conditions
- Breast Neoplasms, Breast Density, Radiographic Image Interpretation, Computer-Assisted
- Trial name
- DECREAS (NCT05181059)
- Testing
- Dual-layer spectral computerized tomography (DLSCT)
- Where
- Netherlands
- Volunteers
- 14 people
- Sponsor
- Rijnstate Hospital
Breast Diseases
Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. African American 2.
- Trial name
- NCT04854304
- Testing
- Fast Breast Abbreviated Magnetic Renounce Imaging
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Abramson Cancer Center at Penn Medicine
Dense Breasts, Breast Cancer
Histology of Functional Density in Premenopausal Breast
The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive…
- Trial name
- NCT01588834
- Testing
- breast biopsy
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Mammography Screening, Breast Density
Mammogram Pretreatment With Ulipristal Acetate
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of dense breast tissue.
- Trial name
- NCT07434128
- Testing
- Biospecimen Collection, Magnetic Resonance Imaging, Mammogram
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- OHSU Knight Cancer Institute
Breast Cancer
Tomosynthesis (TS) or Ultrasound (US) in Mammography-negative Dense Breasts (TOMUS). National Multicenter Trial
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
- Trial name
- TOMUS (NCT03033030)
- Testing
- Ultrasound
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Genova
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS2 (NCT03972605)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Mammographic Breast Density
Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography.
- Trial name
- 4WARD (NCT03199963)
- Testing
- 4-OH tamoxifen
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 223 people
- Sponsor
- BHR Pharma, LLC