Study Summary
This trial is testing whether a new ultrasound guidance and monitoring system is effective for treating early stage breast cancer.
Eligible Conditions
- Breast Cancer Stage 1
- Fibroadenoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: From the date of ablation and imaging to the date of pathological results (approximately 1 week)
Week 1
Number of patients with ablation
R2 value of ablated lesion area
R2 value of ablated lesion depth
R2 value of ablated lesion width
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
HMIgFUS
1 of 1
Experimental Treatment
36 Total Participants · 1 Treatment Group
Primary Treatment: Harmonic motion imaging guided focused ultrasound (HMIgFUS) · No Placebo Group · N/A
HMIgFUS
Procedure
Experimental Group · 1 Intervention: Harmonic motion imaging guided focused ultrasound (HMIgFUS) · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of ablation and imaging to the date of pathological results (approximately 1 week)
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,297 Previous Clinical Trials
1,613,201 Total Patients Enrolled
Elisa Konofagou, PhDPrincipal InvestigatorProfessor of Biomedical Engineering
2 Previous Clinical Trials
56 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are scheduled to receive surgical resection of the tumor by the clinical care team.
References
- 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.
- 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.
- Elisa Konofagou 2022. "Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219695.
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Conditions
Cancer Related
Treatments