Clinical trials: Digital Mammography
Breast Neoplasms
Delphinus SoftVue Prospective Case Collection - ARM 2
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 ARM2 (NCT02977247)
- Testing
- Non-Interventional, Automated Whole Breast Ultrasound
- Where
- 10 sites in United States
- Volunteers
- 1,150 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer
Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.
- Trial name
- NCT00535678
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- GE Healthcare
Breast Cancer
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
- Trial name
- NCT00756834
- Testing
- Screening
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions
Image Correction
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and in standard screening images.
- Trial name
- NCT01885143
- Testing
- Digital Breast Tomosynthesis
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- GE Healthcare
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Breast Cancer
Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on…
- Trial name
- DBT (NCT01373671)
- Testing
- SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
- Where
- United States
- Volunteers
- 764 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
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, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
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.
Breast Cancer
Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
Comparison of the ability of DBT and FFDM to detect breast cancer.
- Trial name
- NCT00535184
- Volunteers
- 220 people
- Sponsor
- GE Healthcare
Breast Cancer
Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States.
- Trial name
- NCT00754598
- Testing
- Tomosynthesis digital mammography imaging system
- Where
- 5 sites in United States
- Volunteers
- 1,183 people
- Sponsor
- Hologic, Inc.
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
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
- Trial name
- NCT02042456
- Testing
- Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound, Full Field Digital Mammography
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Breast Cancer, Benign Breast Condition
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system.
- Conditions
- Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms
- Trial name
- AUDIBLE (NCT07505797)
- Testing
- ATUSA 3D Automated Breast Ultrasound System
- Where
- 2 sites in United States
- Volunteers
- 800 people
- Sponsor
- iSono Health, Inc.
Breast Cancer
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.
- Trial name
- NCT00942396
- Testing
- Full Field Digital Mammogram (Planmed Sophie Nuance)
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Planmed Oy
Breast Cancer
Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography
Comparison of the ability of DBT and FFDM to detect breast cancer.
- Trial name
- NCT00535327
- Volunteers
- 220 people
- Sponsor
- GE Healthcare
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.
Mass Lesion
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
- Trial name
- QTUS (NCT02133417)
- Testing
- Quantitative Transmission Ultrasound
- Where
- 2 sites in United States
- Volunteers
- 287 people
- Sponsor
- QT Ultrasound LLC
Breast Cancer
Xpress Digital Mammography System Images for Computer Aided Detection Development
The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.
- Trial name
- NCT01061138
- Where
- 5 sites in United States
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- Konica Minolta Medical Imaging, USA
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.