Clinical trials: Dense Breast Density
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
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 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 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
Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show > 75% mammographic density.
- Trial name
- NCT01315015
- Testing
- Contrast enhanced breast MRI
- Where
- 9 sites in Netherlands
- Volunteers
- 40,373 people
- Sponsor
- UMC Utrecht
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