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Trial Title:
Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
NCT ID:
NCT06210529
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
a high-intensity focused ultrasound tumor treatment system (Super Knife)
Description:
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.
Arm group label:
Group A (treatmen once)
Arm group label:
Group B (treatmen twice)
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Contact:
Last name:
Nan Niu, MD
Phone:
+8618940256668
Email:
niunannancy@163.com
Investigator:
Last name:
Caigang Liu, PHD
Email:
Principal Investigator
Start date:
October 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06210529
