Clinical trials: Breast Lesion
Breast Cancer
Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection.
- Trial name
- DE-17-17 (NCT04253366)
- Testing
- Clinical investigation device class IIa not marked CE
- Where
- 3 sites in Italy, Spain
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Umbria Bioengineering Technologies
Benign Breast Disease
REGENERA Implant in Excised Non-Malignant Breast Lesions
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom…
- Trial name
- NCT04131972
- Testing
- REGENERA
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Tensive SRL
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
Breast Cancer, Breast Tumor Benign
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2.
- Trial name
- EMBLEDDA-MMG (NCT06428799)
- Testing
- Carebot AI MMG
- Where
- 3 sites in Czechia
- Volunteers
- 122 people
- Sponsor
- Carebot s.r.o.
Breast Lesions
A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
- Trial name
- NCT03520127
- Testing
- Intact Breast Lesion Excision System (BLES)
- Where
- 7 sites in United States
- Volunteers
- 176 people
- Sponsor
- Medtronic Surgical Technologies
Breast Diseases
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.
- Trial name
- NCT04606329
- Testing
- LuminoMark inj.(Conc. for fluorescence), Charcotrace Inj.
- Where
- South Korea
- Volunteers
- 109 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Non-palpable Breast Lesions
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a…
- Trial name
- NCT01574664
- Testing
- RFID Tag (Health Beacon)
- Where
- 3 sites in United States
- Sponsor
- Health Beacons
Breast Cancer With Bone Metastasis
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with…
- Trial name
- NCT00372710
- Testing
- Zoledronic acid
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Novartis
Breast Cancer
Magseed Pro(R)/ Sentimag(R) Gen3
The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B.
- Trial name
- NCT05142787
- Testing
- Magseed Pro(R) and Sentimag(R) Gen3 by Endomagnetics
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 224 people
- Sponsor
- Endomagnetics Ltd.
Breast Neoplasms
Ultrasound Elastography of Breast Lesions
Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional…
- Trial name
- BE1 (NCT00716482)
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 1,681 people
- Sponsor
- SuperSonic Imagine
Mastectomy, Segmental, Breast Neoplasm Malignant Female
Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
The goals of this clinical trial are: demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions demonstrate the safety and performance of REGENERA in terms of investigator's…
- Trial name
- NCT05941299
- Testing
- REGENERA breast implant implantation
- Where
- 9 sites in Italy, Spain
- Volunteers
- 92 people
- Sponsor
- Tensive SRL
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.
Metastatic Cancer, Soft Tissue Sarcoma
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.
- Conditions
- Metastatic Cancer, Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma
- Trial name
- NCT04725331
- Testing
- BT-001, Pembrolizumab [KEYTRUDA®]
- Where
- 5 sites in Belgium, France
- Volunteers
- 31 people
- Sponsor
- Transgene
Breast Cancer, Multiple Myeloma
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion.
- Conditions
- Breast Cancer, Multiple Myeloma, Prostate Cancer
- Trial name
- NCT00029224
- Testing
- zoledronic acid
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Novartis
Mass Lesion
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
- Trial name
- QTUS (NCT02133417)
- Testing
- Quantitative Transmission Ultrasound
- Where
- 2 sites in United States
- Volunteers
- 287 people
- Sponsor
- QT Ultrasound LLC
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, Breast Lesions
Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms
This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence…
- Conditions
- Breast Cancer, Breast Lesions, Breast Mass
- Trial name
- NCT03706534
- Testing
- Ultrasound Image review with CADe, Ultrasound Image review with CADx, Ultrasound Image manual review
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Samsung Medison
Breast Diseases
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy.
- Trial name
- NCT05533099
- Testing
- Observational study
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Tensive SRL
Imaged Breast Abnormalities
Percutaneous Excision Trial
To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.
- Trial name
- I-PET (NCT00720642)
- Where
- 24 sites in United States
- Volunteers
- 1,170 people, healthy volunteers welcome
- Sponsor
- Intact Medical Corporation
Breast Cancer
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
- Trial name
- NCT05757427
- Testing
- Wavelia #2
- Where
- Ireland
- Volunteers
- 73 people
- Sponsor
- MVG Industries SAS