7 Clinical Trials for Various Conditions
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
Breast Fibroadenoma
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger). This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.
Breast Fibroadenoma
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Breast Fibroadenoma
The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.
Fibroadenoma, Breast Cancer Stage I
This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
Breast Fibroadenoma
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.
Benign Breast Conditions; Breast Fibroadenomas
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).
Breast Neoplasms, Breast Diseases, Breast Fibroadenoma, Breast Cancer