Clinical trials: Breast Lesions
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.
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 Diseases
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.
- Trial name
- NCT03743259
- Testing
- LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL, Charcotrace Inj.
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
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
Tumor
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves…
- Trial name
- NCT00413322
- Testing
- belinostat, 5-Fluorouracil (5-FU)
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Valerio Therapeutics
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 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
Metastatic Breast Cancer
Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast…
- Trial name
- NCT05068726
- Testing
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- Where
- 24 sites in United States
- Volunteers
- 51 people
- Sponsor
- GE Healthcare
Skin Lesion
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.
- Trial name
- NCT06025058
- Testing
- Easy Dew MD Regen Cream
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Eun-ji Kim
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
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
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
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, Breast Tumor
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by…
- Conditions
- Breast Cancer, Breast Tumor, Mammary Carcinoma, Human
- Trial name
- ORIGO (NCT06597175)
- Testing
- ORIGO
- Where
- 5 sites in South Korea
- Volunteers
- 300 people
- Sponsor
- Olive Healthcare
Breast Cancer Screening
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening
This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
- Trial name
- NCT04102722
- Testing
- MUST device
- Where
- United States
- Volunteers
- 1,333 people, healthy volunteers welcome
- Sponsor
- Transonic Imaging, Inc.
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
Multiple Myeloma, Breast Cancer
Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic…
- Trial name
- NCT00424983
- Testing
- Zoledronic acid
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
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