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Procedure

HMI-guided Focused Ultrasound for Breast Cancer

N/A

Recruiting

Led By Elisa Konofagou, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women age ≥18

Patients with fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of ablation and imaging to the date of pathological results (approximately 1 week)

Awards & highlights

Study Summary

This trial is testing whether a new ultrasound guidance and monitoring system is effective for treating early stage breast cancer.

Who is the study for?

This trial is for women over 18 with benign tumors or early-stage, non-metastatic breast cancer. Participants should be scheduled for surgical tumor removal and have not had thermal ablation, laser, or radiation therapy on the affected breast. Women with breast implants or who are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The study tests Harmonic Motion Imaging (HMI) as a guide and monitor for Focused Ultrasound Surgery (FUS) in treating benign and stage I non-metastatic breast cancers. It aims to see if HMI can help track the success of ultrasound treatments.See study design

What are the potential side effects?

While specific side effects are not listed, focused ultrasound procedures may cause discomfort, swelling, skin redness or burns at the treatment site. Uncommon risks include bleeding or damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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I have a benign tumor or early-stage breast cancer without lymph node involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of ablation and imaging to the date of pathological results (approximately 1 week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of ablation and imaging to the date of pathological results (approximately 1 week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of ablation and imaging to the date of pathological results (approximately 1 week) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with ablation

R2 value of ablated lesion area

R2 value of ablated lesion depth

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HMIgFUSExperimental Treatment1 Intervention

Each study participants' tumors will be imaged using Harmonic Motion Imaging (HMI), an ultrasound elastography method. A central portion of the tumor will then be ablated and monitored using Harmonic Motion Imaging guided Focus Ultrasound (HMIgFUS). Only one portion of the tumor will be ablated; the other portions of the tumor, including tumor margins, will not be ablated. Following ablation, the tumor will be imaged again using HMI.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,223 Total Patients Enrolled

29 Trials studying Breast Cancer

23,639 Patients Enrolled for Breast Cancer

Elisa Konofagou, PhDPrincipal InvestigatorProfessor of Biomedical Engineering

2 Previous Clinical Trials

56 Total Patients Enrolled

1 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

Media Library

Harmonic motion imaging guided focused ultrasound (HMIgFUS) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05219695 — N/A

Breast Cancer Research Study Groups: HMIgFUS

Breast Cancer Clinical Trial 2023: Harmonic motion imaging guided focused ultrasound (HMIgFUS) Highlights & Side Effects. Trial Name: NCT05219695 — N/A

Harmonic motion imaging guided focused ultrasound (HMIgFUS) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219695 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently active for this investigation?

"The clinical trial is actively enrolling participants, with the first posting on January 19th 2022 and last edits made on February 3rd of this year. Details can be found on clinicaltrials.gov."

Answered by AI

Recent research and studies

Breast Cancer ResearchJournal

Tumor Characterization and Treatment Monitoring of Postsurgical Human Breast Specimens Using Harmonic Motion Imaging (HMI)

Han, Yang, Shutao Wang, Hanina Hibshoosh, Bret Taback, and Elisa Konofagou. 2016. “Tumor Characterization and Treatment Monitoring of Postsurgical Human Breast Specimens Using Harmonic Motion Imaging (HMI)”. Breast Cancer Research. Springer Science and Business Media LLC. doi:10.1186/s13058-016-0707-3.

in VitroJournal

Fast Lesion Mapping During HIFU Treatment Using Harmonic Motion Imaging Guided Focused Ultrasound (hmigfus)<i>in Vitro</i>and<i>in Vivo</i>

Han, Yang, Shutao Wang, Thomas Payen, and Elisa Konofagou. 2017. “Fast Lesion Mapping During HIFU Treatment Using Harmonic Motion Imaging Guided Focused Ultrasound (hmigfus)in Vitroandin Vivo”. Physics in Medicine and Biology. IOP Publishing. doi:10.1088/1361-6560/aa6024.

clinicaltrials.govStudy

Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Elisa Konofagou 2022. "Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219695.