Clinical trials: Mammography
Breast Cancer
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (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
- GEMMA 2 (NCT01104584)
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Where
- 48 sites in United States, Argentina and 7 more
- Volunteers
- 460 people
- Sponsor
- Bayer
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 Cancer
A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined…
- Trial name
- NCT02888366
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- Menssana Research, Inc.
Breast
Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed ultrasound plane waves through the breast, as well as collects reflected ultrasound output.
- Trial name
- ACCRUE (NCT03052166)
- Testing
- QT Ultrasound scan
- Where
- 2 sites in United States
- Volunteers
- 755 people
- Sponsor
- QT Ultrasound LLC
Breast Cancer
Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough…
- Trial name
- MRI-PEM (NCT02426489)
- Testing
- MRI + PEM image
- Volunteers
- 1 people
- Sponsor
- Weinberg Medical Physics LLC
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 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 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 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
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to…
- Trial name
- NCT00990483
- Testing
- 3D mammograpgy system
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Hologic, Inc.
Breast Cancer
Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed…
- Trial name
- NCT01433640
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hologic, Inc.
Breast Cancer
Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States.
- Trial name
- NCT00754598
- Testing
- Tomosynthesis digital mammography imaging system
- Where
- 5 sites in United States
- Volunteers
- 1,183 people
- Sponsor
- Hologic, Inc.
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, 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
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 Diagnosis
PMA Required Pivotal Multi-reader Multi-case Reader Study
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US…
- Trial name
- NCT01952717
- Volunteers
- 236 people
- Sponsor
- Koning Corporation
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
Healthy, Breast Cancer
Validation of a Tear-based Screening Assay for Breast Cancer
This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms.
- Conditions
- Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization
- Trial name
- NCT04928014
- Testing
- Schirmer Strip
- Where
- United States
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Namida Lab
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
Device, Thermography
Study To Evaluate The Sensitivity Of The Linda Thermal Device
The LINDA thermal device consists of a thermal camera attachable to a cell phone and an application for connection with an artificial intelligence program based on a convolutional neural network for classification of…
- Conditions
- Device, Thermography, Mammography
- Trial name
- LINDA (NCT05009277)
- Testing
- Device
- Where
- Brazil
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil