Efficacy of mixed reality assisted partial mastectomy

JRCT ID: jRCT1040240075

Registered date:21/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 21/08/2024
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Overview of the Surgical Technique

Technology: Image-guided technology (VINCENT by FUJIFILM, head-mounted device HoloLens 2 by Microsoft).
Procedure: Breast-conserving surgery is performed, with resection of the tumor and surrounding tissue guided by 3D reconstructed images.
Anatomical Considerations: To confirm the anatomical location of the resected tissue and verify the breast tissue margins.
Effect and Mechanism of Action

Effect: The use of 3D imaging and HoloLens 2 allows for accurate localization of the tumor during surgery, enabling more precise tumor resection.
Mechanism of Action: Image-guided technology clarifies the three-dimensional spatial relationship of the tumor, contributing to the reduction of positive breast margins.

Outcome(s)

• Primary Outcome: Surgical Time, Blood Loss, Secondary Additional Resection
• Secondary Outcome: cancer-positive at the edge of the breast tissue margin

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Disease and Diagnostic Methods
- Disease: Early-stage breast cancer.
- Diagnostic Methods: Diagnosis is made in accordance with the "Breast Cancer Treatment Guidelines, 8th Edition," using mammography, ultrasound, and, if necessary, MRI or biopsy.

2) Stage and Type of Cancer
- Stage: Stage I or Stage II breast cancer.

3) Age
- Age: Patients aged 20 years or older.

4) Sex
- Sex: Female.

5) Performance Status
- Performance Status (ECOG):Patients with an ECOG performance status of 1 or lower.

6) Written Consent from Patients
- Written Consent: Patients who have provided written consent to participate in this study after receiving sufficient informed consent and of their own free will.

Exclude criteria

1) Patients who have participated in other clinical trials (including drug trials) within the past 3 months.
2) Patients who are receiving preoperative hormone therapy (such as oral anastrozole) or preoperative chemotherapy.
3) Patients with significant comorbidities (such as heart failure, progressive liver or kidney disease, severe diabetes, etc.).
4) Patients whom the principal investigator or sub-investigator deems inappropriate for inclusion in the study.

Related Information

• Primary Sponsor: Hirofumi Terakawa