Non-invasive ultrasound treatment for breast cancer
A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
This study is testing a new non-invasive ultrasound treatment called Super Knife to see if it can safely target and destroy breast cancer tumors in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06210529 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the use of a high-intensity focused ultrasound tumor treatment system, known as Super Knife, to non-invasively treat breast cancer. The approach aims to target and destroy tumor cells while minimizing damage to surrounding healthy tissue. Eligible participants include women with confirmed invasive breast cancer who meet specific criteria regarding tumor size and health status. The study seeks to evaluate the effectiveness and safety of this innovative treatment method.
Who should consider this trial
Good fit: Ideal candidates are women with invasive breast cancer tumors measuring 2 cm or larger, without prior treatment for breast cancer.
Not a fit: Patients with inflammatory breast cancer, bilateral breast cancer, or those who have received prior treatment for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative for breast cancer patients, potentially improving outcomes and reducing recovery times.
How similar studies have performed: While the use of high-intensity focused ultrasound is gaining interest, this specific application for breast cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Nan Niu, Phd
- Email: niunannancy@163.com
- Phone: +8618940256668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.