Clinical trials: Mammography Screening
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
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
Multicenter Hologic Tomosynthesis Study
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study.
- Trial name
- NCT00971087
- Testing
- Hologic Selenia Dimensions Digital Breast Tomosynthesis System
- Where
- 22 sites in United States
- Volunteers
- 3,521 people
- Sponsor
- Hologic, Inc.
Breast Screening
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development.
- Trial name
- NCT06636539
- Testing
- CEM Software in New Mammography Device
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Hologic, 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 Health
Image Quality Assessment for Screening and Diagnostic Mammography
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.
- Trial name
- NCT02786004
- Testing
- Full Field Digital Mammography, Digital Breast Tomosynthesis
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- GE Healthcare
Screening Mammogram
A Clinical Analysis of Bella Blankets® Protective Coverlets
This study will collect and compare clinical image quality measurements of randomly scheduled, asymptomatic, screening mammography patients, right breast mammogram performed with and without the use of Bella Blankets protective…
- Trial name
- NCT03622294
- Testing
- Bella Blankets protective coverlets
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Beekley Medical
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.
Breast Neoplasms
Early Detection of Breast Cancer
The TriNetra™ Breast test is intended for use as a breast cancer screening test that evaluates Circulating Tumor Cells (CTCs) associated with breast cancer.
- Trial name
- NCT06043661
- Where
- United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Datar Cancer Genetics Inc
Breast Cancer
Collection of FUJIFILM's 3Dimensional Mammograms
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject.
- Trial name
- 3DM (NCT01542814)
- Testing
- 3Dimensional Mammography, 2D FFDM
- Where
- 3 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
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
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
- Trial name
- NCT05615298
- Testing
- Mammography
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Lunit Inc.
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, 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
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
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
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, Abnormal Mammogram, Unspecified
Breath Test to Predict Breast Cancer and Outcome of Mammography
To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.
- Trial name
- NCT04755829
- Testing
- BreathX test for breath VOCs
- Where
- 3 sites in Germany, Netherlands and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Menssana Research, 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
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.