Clinical trials: Mammography
Breast Cancer
The PIONEER-01 Study of the Imagio Breast Imaging System
This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses.
- Trial name
- NCT01943916
- Testing
- Imagio OA/US (US and OA/US), Imagio gray scale ultrasound
- Where
- 16 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Seno Medical Instruments Inc.
Breast Cancer
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or…
- Trial name
- NCT00999596
- Where
- 3 sites in United States, Germany
- Volunteers
- 107 people
- Sponsor
- Philips Healthcare
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 Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
- Conditions
- Breast Cancer, Tumors, Breast, Cancer Screening
- Trial name
- ADAPT (NCT02306265)
- Testing
- FFDM, DBT
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- GE Healthcare
Breast Cancer
Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.
- Trial name
- NCT02615509
- Testing
- Imaging on experimental tomo device
- Where
- United States
- Volunteers
- 347 people
- Sponsor
- Philips Digital Mammography Sweden AB
Breast Cancer
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis.
- Trial name
- NCT01303419
- Testing
- CE-BMRI, DE-CEDM
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 224 people
- Sponsor
- GE Healthcare
Breast Cancer
Multicenter Hologic Tomosynthesis Study
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study.
- Trial name
- NCT00971087
- Testing
- Hologic Selenia Dimensions Digital Breast Tomosynthesis System
- Where
- 22 sites in United States
- Volunteers
- 3,521 people
- Sponsor
- Hologic, Inc.
Breast Cancer
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle.
- Trial name
- NCT03611543
- Testing
- Standard of Care Flat Paddle, Investigational Curved Paddle
- Where
- 4 sites in United States
- Volunteers
- 443 people, healthy volunteers welcome
- Sponsor
- Hologic, Inc.
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
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
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 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, 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
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, 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
Breast Cancer
Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.
- Trial name
- NCT02511730
- Testing
- FFDM Plus DBT, FFDM
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, 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.
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 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
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