None listed
Conditions
Interventions
Medical Device : The test group applies a 3D printing breast surgery guide (3DP-BSG). Produce 3DP-BSG based on medical images (MRI/CT) for suspected single breast cancer patients who are planning brea
Sponsors
Anymedi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| margin positivity | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactSaebyeol Lee
Asan Medical Center
Outcome results
None listed