News | Focused Ultrasound Therapy | May 04, 2017

U.S. Clinical Data Supports Echotherapy With Echopulse for Breast Fibroadenomas

Data presented at American Society of Breast Surgeons meeting shows echotherapy was well-tolerated and resulted in minimal side effects

U.S. Clinical Data Supports Echotherapy With Echopulse for Breast Fibroadenomas

May 4, 2017 — Theraclion recently announced the presentation of data from the U.S. feasibility trial of echotherapy with Echopulse, a non-invasive treatment employing ultrasound-guided high-intensity focused ultrasound (HIFU), in women with breast fibroadenomas. Results were presented at The American Society of Breast Surgeons (ASBrS) Annual Meeting, held April 26-30 in Las Vegas.

The single-arm feasibility study was led by David Brenin, M.D., chief of breast surgery, co-director of the University of Virginia Breast Care Program, associate professor of surgery at UVA’s School of Medicine and principal investigator of the ongoing pivotal trial. The study enrolled 20 patients with 1 cm or larger palpable breast fibroadenomas to assess the safety and feasibility of a single Echopulse treatment. Fifty percent of patients reported a painful mass prior to enrollment. The study showed that echotherapy was well-tolerated. Pain and discomfort were the most commonly-reported side effects but remained minimal. Patient satisfaction after three months was 4.4 and the likelihood that they would recommend the treatment to a friend or family member was 4.7 (scale of 1-5, in which 5 indicated most satisfied). Long-term cosmetic outcome, reduction in breast fibroadenoma size and patient experience are currently under investigation.

Following this initial feasibility study, Theraclion has recently launched a U.S. pivotal trial evaluating the safety and efficacy of Echopulse. The pivotal trial is currently enrolling patients and is also being led by Brenin. The trial will enroll approximately 100 patients at four centers in the United States — University of Virginia School of Medicine, NYU Langone Bellevue, Montefiore Medical Center (NY) and New York-Presbyterian/Columbia University Medical Center — and two in Europe with Tübingen University Hospital, Germany and the University Hospital of Endocrinology in Sofia, Bulgaria.

Brenin said, “Although benign, breast fibroadenomas can cause discomfort, and the discovery of a lump in their breast can create anxiety in women. The current standard of care is surgery, which can cause significant pain and discomfort requiring medication and inevitably leads to scar formation. Echopulse is a very promising non-invasive alternative approach to treat the condition without the complications of surgery.”

Theraclion Chief Medical Officer Michel Nuta, M.D., said the results are consistent with clinical evaluations performed in Europe, where Echopulse is currently indicated with a CE Mark for this condition. Nuta said the company anticipates announcing top-line results for the U.S. clinical trial in 2019.

For more information: www.theraclion.com

Related Content

Culturally relevant strategies are necessary to improve preventive health care in this rapidly growing population, Rutgers researchers say

Getty Images

News | Women's Health | October 28, 2020
October 28, 2020 — Indian and Pakistani women are diagnosed with...
Study of Penn Medicine patients shows abbreviated MRI may be a valuable supplemental screening for women with dense breasts
News | MRI Breast | October 28, 2020
October 28, 2020 — Beth Reisboard, 76, was relieved in 2018 when she received the results from her annual...
An example of a HeartFlow FFR-CT image showing the blood flow through what looked like a significant blockage on CT angiography alone, actually was not flow-limiting based on computational fluid dynamics. Use of the technology was supposed to reduce the number of diagnostic catheterizations in the FORECAST trial, but the costs of FFR-CT were not offset enough to show cost savings.

An example of a HeartFlow FFR-CT image showing the blood flow through what looked like a significant blockage on CT angiography alone, actually was not flow-limiting based on computational fluid dynamics. Use of the technology was supposed to reduce the number of diagnostic catheterizations in the FORECAST trial, but the costs of FFR-CT were not offset enough to show cost savings.

Feature | CT Angiography (CTA) | October 23, 2020
October 22, 2020 – In the FORECAST randomized clinical trial, the use of ...
This illustration show the complexity of the data obtained from one single patient with moderate/severe traumatic brain injury. Different imaging approaches and techniques have their own unique sensitivity in assessing different aspects of neuroanatomy and neuropathology. What can be seen on images also changes with time since injury. Data from comprehensive clinical and functional assessments using a range of other tools is also important for evaluating patient outcome. Through data harmonization and large

This illustration show the complexity of the data obtained from one single patient with moderate/severe traumatic brain injury. Different imaging approaches and techniques have their own unique sensitivity in assessing different aspects of neuroanatomy and neuropathology. What can be seen on images also changes with time since injury. Data from comprehensive clinical and functional assessments using a range of other tools is also important for evaluating patient outcome. Through data harmonization and large-scale analyses of data combined across multiple research sites, the ENIGMA Brain Injury will develop and test methods and procedures for making sense of the complexity in this data. Images courtesy of Olsen et al., Brain Imaging and Behavior, 2020

News | Magnetic Resonance Imaging (MRI) | October 23, 2020
October 23, 2020 — Trau...
Mammography, which is an X-ray picture of the breast, is efficient also for women over the age of 70.

Getty Images

News | Mammography | October 22, 2020
October 22, 2020 — ...
The fMRI hyperscanning environment.

(A) The fMRI hyperscanning environment. The clinician (1) and patient (2) were positioned in two different 3T MRI scanners. An audio-video link enabled online communication between the two scanners (3), and video images were used to extract frame-by-frame facial expression metrics. During simultaneous acquisition of blood oxygen level–dependent (BOLD)–fMRI data, the clinician used a button box (4) to apply electroacupuncture (EA) treatment (real/sham, double-blind) to the patient (5) to alleviate evoked pressure pain to the leg (6; Hokanson cuff inflation). Pain and affect related to the treatment were rated after each trial. (B) Study overview. After an initial behavioral visit, each individual participated in a Clinical-Interaction (hyperscan preceded by a clinical intake) and No-Interaction condition (hyperscan without a preceding intake), in a counterbalanced order, with two different partners. (C) Experimental protocol. Each hyperscan was composed of 12 repeated trials (four verum EA, four sham EA, and four no treatment) in a pseudo-randomized order. After a resting period (far left), both participants were shown a visual cue to indicate whether the next pain stimulus would be treated (green frame) or not treated (red frame) by the clinician. These cues prompted clinicians prepare to either apply or not apply treatment while evoking corresponding anticipation for the patient. Following the anticipation cue, moderately painful pressure pain was applied to the patient’s left leg, while the clinician applied or did not apply treatment, respectively. After another resting period, participants rated pain (patients), vicarious pain (clinicians), and affect (both) using a visual analog scale (VAS).

News | Clinical Trials | October 22, 2020
October 22, 2020 — The potential impact of the patient-clinician relationship on a patient's response to treatment is
Lesion was originally reported as indeterminate enhancing mass, and outside report recommended biopsy. Classic features of benign hemangioma are shown. Error was attributed to faulty reasoning. A, Axial MR image obtained 5 minutes after contrast agent administration shows peripheral nodular discontinuous enhancement. B, Axial MR image obtained 10 minutes after contrast agent administration shows centripetal progression of enhancement (arrow). C, Axial fast imaging employing steady-state acquisition (FIESTA)

Lesion was originally reported as indeterminate enhancing mass, and outside report recommended biopsy. Classic features of benign hemangioma are shown. Error was attributed to faulty reasoning. A, Axial MR image obtained 5 minutes after contrast agent administration shows peripheral nodular discontinuous enhancement. B, Axial MR image obtained 10 minutes after contrast agent administration shows centripetal progression of enhancement (arrow). C, Axial fast imaging employing steady-state acquisition (FIESTA) MR image shows lesion is homogeneously hyperintense compared with liver parenchyma. Image courtesy of American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

News | Magnetic Resonance Imaging (MRI) | October 21, 2020
October 21, 2020 — According to an artic...
Rebrand reflects Volpara Health's mission to prevent advanced-stage breast cancer
News | Breast Imaging | October 19, 2020
October 19, 2020 — Volpara Solutions, a leader in AI-powered breast density assessment, announced that it has changed