A Randomized, prospective trial of 3D printed patient-customized surgical guide for breast conserving surgery- comparative evaluatio
- Conditions
- Neoplasms
- Registration Number
- KCT0008122
- Lead Sponsor
- Anymedi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 990
•Female patients from 20 to 79 years of age
•Patients diagnosed with breast cancer by histologic diagnosis
•Patients with suspected solitary breast cancer for whom breast-conserving surgery is planned.
•Subjects who fully understands and agrees in writing to the Informed consent form
• Patients who have contraindications of MRI
? Those with an inserted electrical device, clip for the prevention of aneurysm, artificial of metallic material around the eyeball
? Patients who have Claustrophobia
? Patients with difficulty using gadolinium-based angiography - severe allergic or impaired of kidney function (creatinine > 2.0)
? Pregnant
• Difficult partial resection due to large calcification lesions
• Patients with multicentric breast cancer based on initial imaging tests
• Patients deemed unsuitable to participate in this clinical trial at the Investigator's discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method margin positivity
- Secondary Outcome Measures
Name Time Method local recurrence rate;Distance from tumor to edge of specimen;overall survival;Disease-free survival rate;Volume of the removed specimen;Weight of removed specimen;Surgery time;Patient satisfaction;Surgeon's Satisfaction