A randomized, prospective, multicenter study to validate the usefulness of 3D-printing surgical guides for breast-conserving surgery in breast cancer patients treated with neoadjuvant chemotherapy

A Randomized, prospective, multicenter trial of 3d printing, a patient-specific surgical guide for breast-conserving surgery after neoadjuvant chemotherapy: comparative evaluation according to the presence or absence of surgical guide.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004469

Enrollment

488

Registered

2019-11-25

Start date

2019-12-09

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

None listed

Interventions

Medical Device : The experimental group applies the 3D printing breast surgery guide (3DP-BSG). 3DP-BSG is prepared based on pre- and post-treatment medical images (MRI / CT) in patients undergoing ne

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: •Female patients from 20 to 79 years of age •Patients who received or is receiving neoadjuvant chemotherapy, after diagnosed with invasive breast cancer by histology •Patients who are scheduled to have breast-conserving surgery after neoadjuvant chemotherapy •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 deemed unsuitable to participate in this clinical trial at the Investigator's discretion

Design outcomes

Primary

Measure	Time frame
Tumor at first resection margin	—

Secondary

Measure	Time frame
Distance from tumor to edge of specimen;Volume of the removed specimen;Weight of removed specimen;Surgery time;Patient satisfaction;Surgeon's Satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactMunju Jeong

Asan Medical Center

mjoo0608@gmail.com+82-2-3010-6194

Outcome results