Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Niu, Phd; Phone Number: +8618940256668; Email: niunannancy@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital Of China Medical University
      • Contact: Nan Niu, MD; Phone Number: +8618940256668; Email: niunannancy@163.com
      • Principal Investigator: Caigang Liu, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (treatmen once)	Device: a high-intensity focused ultrasound tumor treatment system (Super Knife); All participants will be randomly divided into groups A and B. Participants in group A will receive a high-intensity focused ultrasound tumor treatment (Super Knife) once, and participants in group B will receive treatment twice (4 weeks, one cycle).. Breast cancer surgery was performed at 3 months ± 1 week after the Super Knife treatment.
Experimental: Group B (treatmen twice)	Device: a high-intensity focused ultrasound tumor treatment system (Super Knife); All participants will be randomly divided into groups A and B. Participants in group A will receive a high-intensity focused ultrasound tumor treatment (Super Knife) once, and participants in group B will receive treatment twice (4 weeks, one cycle).. Breast cancer surgery was performed at 3 months ± 1 week after the Super Knife treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response (pCR)	pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes.	1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease.	In the first month, the second month, the third month
Objective response rate	The percentage of patients whose therapeutic intervention has led to a complete response, partial response.	In the first month, the second month, the third month
Adverse events	Adverse events during and after the treatment	1 month after surgery

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MUKDEN 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No