Clinical trials: Dense Breasts
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 Screening
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be…
- Trial name
- NCT05268224
- Testing
- Schirmer Strip
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Namida Lab
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 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, 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
A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8…
- Trial name
- NCT03288792
- Testing
- RI8 device imaging
- Where
- 5 sites in United States
- Volunteers
- 435 people, healthy volunteers welcome
- Sponsor
- Real Imaging Ltd.
Breast Neoplasms
MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue
Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast…
- Trial name
- NCT02013726
- Testing
- MBI Scan: The LumaGEM®, 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
- Volunteers
- healthy volunteers welcome
- Sponsor
- Gamma Medica, Inc.
Breast Cancer Detection, Breast Neoplasm
Molecular Breast Imaging (MBI)-Guided Biopsy
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts.
- Conditions
- Breast Cancer Detection, Breast Neoplasm, Molecular Imaging, Biopsy
- Trial name
- MBI-GB-Pilot (NCT07114679)
- Testing
- Molecular Breast Imaging, MBI-guided biopsy
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Smart Breast Corp.
Breast Cancer
Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy.
- Trial name
- NCT00394251
- Testing
- Adriamycin and Cytoxan (AC), ABI-007, Taxol
- Where
- 27 sites in United States
- Volunteers
- 197 people
- Sponsor
- Celgene
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.
Triple Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast…
- Trial name
- NCT05112536
- Testing
- Trilaciclib, Cylophosphamide, Doxorubicin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- G1 Therapeutics, Inc.
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
HER2-normal
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
- Trial name
- NCT01328249
- Testing
- eribulin mesylate
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
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
Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis
The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts.
- Trial name
- AMELIA (NCT03616457)
- Testing
- Automated Breast Ultrasound (ABUS)
- Sponsor
- GE Healthcare
Breast Cancer
Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer
In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.
- Trial name
- NCT00107094
- Testing
- Abraxane
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Celgene Corporation
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 Adenocarcinoma, Estrogen Receptor Positive
PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer
This phase I/II trial studies the side effects and the best dose of triciribine phosphate when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients…
- Conditions
- Breast Adenocarcinoma, Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma
- Trial name
- NCT01697293
- Testing
- Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Prescient Therapeutics, Ltd.
Breast Cancer
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin.
- Trial name
- NCT00093145
- Testing
- Albumin-bound paclitaxel, Carboplatin, Herceptin®
- Where
- 14 sites in United States
- Volunteers
- 32 people
- Sponsor
- Celgene
Mammographic Breast Density
Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography.
- Trial name
- 4WARD (NCT03199963)
- Testing
- 4-OH tamoxifen
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 223 people
- Sponsor
- BHR Pharma, LLC