Clinical trials: Mammography
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
Acquisition of Breast Mammography Images
This is a case collection study of breast images using standard and new mammography technology.
- Trial name
- NCT02156258
- Testing
- FFDM Mammography, DBT Mammography
- Where
- 5 sites in United States
- Volunteers
- 1,232 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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, 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 Cancer Biomarker Sample Collection for the dtectDx Assay Verification
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins in your blood samples.
- Trial name
- NCT01839045
- Where
- 8 sites in United States
- Volunteers
- 350 people
- Sponsor
- Provista Diagnostics, 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 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
Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on…
- Trial name
- DBT (NCT01373671)
- Testing
- SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
- Where
- United States
- Volunteers
- 764 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
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
Breast Cancer
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic…
- Trial name
- NCT00484614
- Testing
- Positron Emission Mammography, Magnetic Resonance Imaging
- Where
- 6 sites in United States
- Volunteers
- 472 people
- Sponsor
- Naviscan PET Systems
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
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
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.
Wrinkle
Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906
Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.
- Trial name
- NCT04717934
- Testing
- GAL1906
- Where
- 14 sites in United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Breast Cancer
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject…
- Trial name
- NCT03243877
- Testing
- MammoAlert Screening Test
- Where
- 7 sites in India
- Volunteers
- 2,458 people
- Sponsor
- POC Medical Systems, Inc.
Breast Cancer, Diagnostic Imaging
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of…
- Trial name
- NCT01067976
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Where
- 40 sites in United States, Argentina and 7 more
- Volunteers
- 446 people
- Sponsor
- Bayer
Breast Cancer
A Multi-Reader Multi-Case Pivotal Trial
The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.
- Trial name
- NCT02692209
- Testing
- FFDM Plus DBT, FFDM Alone
- Where
- 5 sites in United States
- Volunteers
- 298 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer Screening
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
- Trial name
- NCT04102722
- Testing
- MUST device
- Where
- United States
- Volunteers
- 1,333 people, healthy volunteers welcome
- Sponsor
- Transonic Imaging, 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 Cancer
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
- Trial name
- NCT00759447
- Testing
- Genesis and Gemini, Investigational 3D Mammography system
- Volunteers
- 240 people
- Sponsor
- Hologic, Inc.