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

NCT ID: NCT06210529

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (treatmen once)

Group Type: EXPERIMENTAL

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

Intervention Type: 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 B (treatmen twice)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caigang Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Nan Niu, Phd

Role: CONTACT

niunannancy@163.com

+8618940256668

Facility Contacts

Nan Niu, MD

Role: primary

niunannancy@163.com

+8618940256668

Other Identifiers

MUKDEN 10

Identifier Type: -

Identifier Source: org_study_id