Clinical trials: Digital Mammography
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, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
- Conditions
- Breast Cancer, Tumors, Breast, Cancer Screening
- Trial name
- ADAPT (NCT02306265)
- Testing
- FFDM, DBT
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- GE Healthcare
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
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
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
- Trial name
- NCT02511730
- Testing
- FFDM Plus DBT, FFDM
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast
Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output.
- Trial name
- ACCRUE (NCT03052166)
- Testing
- QT Ultrasound scan
- Where
- 2 sites in United States
- Volunteers
- 755 people
- Sponsor
- QT Ultrasound LLC
Breast Cancer
Acquisition of Breast Mammography Images
This is a case collection study of breast images using standard and new mammography technology.
- Trial name
- NCT02156258
- Testing
- FFDM Mammography, DBT Mammography
- Where
- 5 sites in United States
- Volunteers
- 1,232 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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
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, 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.
Routine Screening Mammography
Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
- Trial name
- NCT07471750
- Testing
- DBT HR mode image acquisition
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.