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Combined liquid nitrogen tumor ablation for breast tumors

Combined liquid nitrogen tumor ablation for breast tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079380
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-04
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast tumor

Interventions

Experimental group:Combined liquid nitrogen tumor ablation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Bresat Fibroadenoma 1. Lesions can be identified on ultrasound. 2. The maximum diameter of the lesion was =3cm, and the distance from the chest muscle or skin was =0.5cm. 3. The pathological diagnosis was fibroadenoma of breast. Breast Cancer 1.Low-Risk Early-Stage Breast Cancer :women age 60 years or older with unifocal invasive ductal carcinoma size 1.5 cm or smaller,a low to intermediate histology grade (Nottingham grade =2) ,and with a low-risk cancer profile including estrogen receptor (ER) positivity and/or progesterone receptor (PR) positivity, human epidermal growth factor receptor 2 (HER2) negativity.The patients included in the trial are clinically lymph node-negative on ultrasound and physical evaluation and agree to breast ablation instead of surgery. 2.Patients with surgical indications, who cannot tolerate surgery due to old age, serious organ dysfunction, or refuse surgery. 3.Advanced breast cancer, such as skin rupture, distant metastasis and other stage III and IV breast cancer can not be treated by conventional surgery, and are not sensitive to radiotherapy, chemotherapy, etc. as local palliative treatment for breast cancer.

Exclusion criteria

Exclusion criteria: Breast Fibroadenoma 1.The lesion was poorly developed on ultrasound. 2. Needle biopsy suggests cystosarcoma or other malignant lesion. 3. The needle biopsy showed fibroadenoma, but it did not match the imaging or the doctor's physical examination .If the ultrasound image shows malignant signs, it is also excluded. 4.General surgical contraindications include: pregnant women, breastfeeding women and so on. Breast Cancer 1. Systemic cachexia or severe insufficiency of liver, kidney and cardiopulmonary function; Patients with severe coagulation mechanism disorders; Those who are unconscious or unable to cooperate. 2. Patients without informed consent 3. For patients with Low-Risk Early-Stage Breast Cancer,followings are not included: patients with an extensive intraductal component (EIC) (defined as a core biopsy specimen containing 25% or more of intraductal neoplasia),multifocal and/or multicentric disease, the presence of multifocal calcifications on mammogram, prior surgical biopsy for diagnosis or treatment of the index lesion, patients not suitable for cryoablation according to multi-disciplinary team (MDT), patients receiving neoadjuvant therapy in any form,patients with contraindications to radiotherapy and patients with axillary lymph node metastasis.

Design outcomes

Primary

MeasureTime frame
complete response;incomplete response;

Countries

China

Contacts

Public ContactJiandong Wang

Chinese PLA General Hospital

761402092@qq.com+86 139 1026 9069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026