Clinical trials: Mammography
MR Mammography With Dotarem
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013.
- Trial name
- NCT03041298
- Testing
- MR mammography with Dotarem
- Volunteers
- 1,537 people, healthy volunteers welcome
- Sponsor
- Guerbet
Breast Cancer
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
- Trial name
- NCT02042456
- Testing
- Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound, Full Field Digital Mammography
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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
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
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
- Trial name
- 3DM (NCT01928992)
- Testing
- 3D, 2D
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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 Neoplasms
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer
The Study Objective is to evaluate the diagnostic efficacy of the liquid biopsy system versus the gold standard mammography (or MRI, or Ultrasound) diagnosis in patients with suspected breast cancer.
- Trial name
- ARNABreast (NCT04890340)
- Testing
- ARNA Breast
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- ARNA Genomics US Inc.
Routine Screening Mammography
Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
- Trial name
- NCT07471750
- Testing
- DBT HR mode image acquisition
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Cancer
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.
- Trial name
- NCT05300464
- Testing
- Clinical investigation medical device class IIa marked CE
- Where
- 4 sites in Italy, Spain
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Umbria Bioengineering Technologies
Breast Cancer
OctavaPink for Women With Dense Breast After Negative Mammography
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and…
- Trial name
- NCT02209389
- Testing
- MRI
- Where
- 7 sites in United States, Israel and 1 more
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- Eventus Diagnostics Ltd
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 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.
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
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 Diagnosis
Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in…
- Trial name
- CEDEM (NCT02608281)
- Testing
- CONTRAST ENHANCED DUAL ENERGY (CEDEM)
- Where
- Austria
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Siemens Healthcare QT
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
Mammography
Prospective Case Collection Study for New Mammography Technologies
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
- Trial name
- NCT05199701
- Testing
- Mammography
- Where
- 15 sites in United States
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Hologic, Inc.
Breast Cancer
Xpress Digital Mammography System Images for Computer Aided Detection Development
The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.
- Trial name
- NCT01061138
- Where
- 5 sites in United States
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- Konica Minolta Medical Imaging, USA
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.