Clinical trials: Breast Cancer Screening and Diagnosis
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, 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
Cancer, Lung, Cancer, Breast
Early Detection of Five Common Cancers Using the ctDNA Analysing Test
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).
- Conditions
- Cancer, Lung, Cancer, Breast, Cancer Liver, Cancer, Colorectal
- Trial name
- K-DETEK (NCT05227261)
- Where
- Vietnam
- Volunteers
- 9,057 people, healthy volunteers welcome
- Sponsor
- Gene Solutions
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, 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
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay
Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer.
- Trial name
- TM-B1 (NCT03343691)
- Testing
- Screening Population, Breast Cancer Population
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Todos Medical, Ltd.
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, 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 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 Cancer Female
SNAPS Breast Cancer Patient Study Breast Cancer Patients
Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states.
- Trial name
- NCT05370300
- Testing
- Blood test
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Immunis.AI
Cancer Colon, Cancer, Liver
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)
To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE.
- Conditions
- Cancer Colon, Cancer, Liver, Cancer, Lung, Cancer, Breast
- Trial name
- K-ACCELERATE (NCT06391749)
- Where
- Vietnam
- Volunteers
- 1,000 people
- Sponsor
- Gene Solutions
Breast Cancer
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario.
- Trial name
- IMA-L2 (NCT05800132)
- Testing
- MammoScreen
- Where
- 7 sites in France
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Therapixel
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
Metastatic Breast Cancer
Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives: 1.
- Trial name
- NCT01555944
- Where
- 24 sites in Belgium
- Volunteers
- 60 people
- Sponsor
- Teva Pharma
Breast Cancer
Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will…
- Trial name
- NCT00821613
- Where
- 6 sites in Israel
- Volunteers
- 1,827 people, healthy volunteers welcome
- Sponsor
- Real Imaging Ltd.
Breast Cancer, Colorectal Cancer
Detection of Cancer in Breath Samples by Trained Detection Dogs
The goal of this study is to show that trained detection dogs can identify breast, lung, prostate or colorectal cancer by sniffing masks containing breath samples.
- Conditions
- Breast Cancer, Colorectal Cancer, PROSTATE CANCER, Lung Cancer
- Trial name
- NCT06255041
- Where
- 2 sites in Israel
- Volunteers
- 1,386 people, healthy volunteers welcome
- Sponsor
- SpotitEarly
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, Breast - Female
An Investigation Into Dielectric Testing for the Evaluation and Characterisation of Breast Tissue Using a Novel Time-Domain Bioimpedance Tool
Capacitance measures a material's ability to store the movement of electrical energy in the electric field. Different of the human body are known to have different capacitance values.
- Trial name
- DiTECT (NCT07782814)
- Testing
- TD-BIS scanner
- Where
- United Kingdom
- Volunteers
- 220 people
- Sponsor
- Zedsen Limited
Breast Cancer, Breast Cancer Female
Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods.
- Trial name
- NCT03480659
- Where
- Kazakhstan
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- HKGepitherapeutics
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