Clinical trials: Breast Screening
Women's Health: Neoplasm of Breast
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity>75% and specificity>90% in breast cancer (BC)…
- Trial name
- NCT06291896
- Testing
- MammoWave
- Where
- 10 sites in Italy, Poland and 3 more
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Umbria Bioengineering Technologies
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.
Brain Cancer, Breast Cancer
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types.
- Conditions
- Brain Cancer, Breast Cancer, Bladder Cancer, Cervical Cancer
- Trial name
- CAMPERR (NCT05366881)
- Where
- 17 sites in United States
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- Adela, 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, Ovarian Cancer
Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
- Trial name
- NCT05223218
- Testing
- Schirmer strip, a Class I Medical Device typically used to test for dry eye.
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Namida Lab
Thoracic Cancer, Ovarian Cancer
Project CADENCE (CAncer Detected Early caN be CurEd)
With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be…
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer
- Trial name
- CADENCE (NCT05633342)
- Where
- Singapore
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- MiRXES Pte Ltd
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 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 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.