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

NCT06210529 | Unknown DMC

• 1 other identifier: MUKDEN 10
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Disease control rate

  In the first month, the second month, the third month

• Objective response rate

  In the first month, the second month, the third month

• Adverse events

  1 month after surgery

Study Arms (2)

Group A (treatmen once)

EXPERIMENTAL

Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)

Group B (treatmen twice)

EXPERIMENTAL

Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)

Interventions

a high-intensity focused ultrasound tumor treatment system (Super Knife) DEVICE

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.

Group A (treatmen once); Group B (treatmen twice)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nan Niu, Phd

CONTACT

+8618940256668; niunannancy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 18, 2024
• Study Start: October 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)