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Trial Title:
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
NCT ID:
NCT06288620
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Microwave Ablation
Description:
Preoperative US-guided microwave ablation of breast cancer
Arm group label:
Microwave Ablation
Summary:
Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been
attempted to treat breast cancer of small lesions . However, the optimal indications for
MWA in the treatment of breast cancer is unknown. This prospective, open-label,
single-arm phase II clinical study was conducted to evaluate the efficacy and safety of
MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the
immune activating effect.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. female patients aged 18-70 years;
2. patients with newly diagnosed invasive breast cancer confirmed by core needle
biopsy;
3. the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography),
breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were
performed at the same time, and the difference of the largest diameter between
breast US and MRI was less than 0.5 cm;
4. the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging
Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
5. the tumor without adhesion to chest wall, nipple or skin;
6. patients without distant metastasis;
7. Karnofsky performance status greater than 70%.
Exclusion Criteria:
1. multicentric or multifocal breast tumor;
2. the tumor located on nipple and areola area;
3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignant
calcification on breast X-ray or segmental distribution, non-mass enhancement,
ductal or linear enhancement > 2.5 cm on MRI);
4. extensive intraductal component in invasive cancer (more than 50% of the tumor
volume) confirmed by pathology;
5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing
adenosis;
6. patients who were pregnant or breastfeeding;
7. patients with evidence of coagulopathy, chronic liver diseases or renal failure;
8. patients with previous treatment including chemotherapy, targeted drug therapy, or
local radiation therapy, etc;
9. patients with substance abuse, or mental or psychological disorders that may
interfere with study compliance;
10. any condition that is unstable or likely to compromise the patient's safety and
compliance;
11. patients enrolled in other clinical trials;
12. diseases or symptoms that other investigators consider unsuitable for participation.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Zhou, Professor
Start date:
February 25, 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06288620