Clinical trials: Normal Breast Screening
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.
Early-Stage Breast Carcinoma
Circadian Thermal Sensing to Detect Breast Disease
The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a…
- Trial name
- NCT02511301
- Testing
- Cyrcadia CBR™ device placement for abnormality screening
- Where
- 2 sites in United States
- Volunteers
- 173 people
- Sponsor
- Cyrcadia Health
Breast Neoplasms
ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
The purpose of this study is to measure the performance characteristics for the collection, fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE Breast Aspirator across 3 independent labs…
- Trial name
- NCT02218385
- Testing
- ForeCYTE Breast Aspirator
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Atossa Therapeutics, Inc.
Breast Cancer
Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs
The goal of this study is to find out whether a system that uses trained detection dogs and artificial intelligence (AI) can identify breast cancer from a person's breath.
- Trial name
- PINK (NCT07038785)
- Testing
- Breath test
- Where
- 6 sites in United States, Israel
- Volunteers
- 1,204 people, healthy volunteers welcome
- Sponsor
- SpotitEarly
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 Cancer, Breast Diseases
Contrast-Free Magnetic Resonance Imaging for Breast Disease
Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.
- Trial name
- IMOGEN (NCT05006196)
- Testing
- Outpatient MRI
- Where
- United Kingdom
- Volunteers
- 1,030 people, healthy volunteers welcome
- Sponsor
- Perspectum
Breast Cancer
Cone Beam Breast CT for Breast Cancer Screening
Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set.
- Trial name
- NCT05036096
- Testing
- CBBCT Imaging, Digital Mammography
- Where
- 4 sites in United States
- Volunteers
- 1,024 people, healthy volunteers welcome
- Sponsor
- Koning Corporation
Breast Lesions, Breast Cyst
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning
The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of…
- Conditions
- Breast Lesions, Breast Cyst, Early-Stage Breast Cancer, Benign Growth, Breast
- Trial name
- NCT00671385
- Where
- United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Spectros Corporation
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, Liquid Biopsy, Early Detection
Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening
Breast cancer is the most common cancer that spreads beyond the initial layer of tissue it developed in, and grows into surrounding healthy tissue in women worldwide. It is associated with significant illness and death.
- Trial name
- NCT07219277
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Syantra 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
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 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, Breast Cyst
Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
- Trial name
- NCT03475992
- Testing
- Low-power microwave breast imaging system
- Where
- Ireland
- Volunteers
- 25 people
- Sponsor
- MVG Industries SAS
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.
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.