Clinical trials: Mammography Screening
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 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
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
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 Neoplasms, Ultrasonography
Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons
The purpose of this study is to determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense breasts will result in a…
- Trial name
- NCT00649337
- Testing
- Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography
- Where
- United States
- Volunteers
- 4,650 people, healthy volunteers welcome
- Sponsor
- SonoCine, 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 Neoplasms, Breast Cancer Detection
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms.
- Conditions
- Breast Neoplasms, Breast Cancer Detection, Breast Cancer - Female, Breast Cancer Screening
- Trial name
- CARE-MMG-MRMC (NCT07298252)
- Testing
- Carebot AI MMG software analysis
- Where
- 4 sites in Czechia, Slovakia
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Carebot s.r.o.
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 Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-Enrich) 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…
- Trial name
- ADAPT-ENRICH (NCT02540083)
- Testing
- DBT and FFDM
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- GE Healthcare
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, 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, 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 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, Tear
Tear Based Sample Collection Breast Cancer Detection
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
- Conditions
- Breast Cancer, Tear, Breast Cancer Female
- Trial name
- NCT04974567
- Testing
- Schirmer Strip
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Namida Lab