NCT06635096

The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer

A Prospective, Single-center, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study aimed to evaluate the efficacy and safety of MTT in the treatment of early-stage invasive breast cancer, and to explore the ablation-induced immune activating response.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	Multimodal Tumor Thermal Therapy System (Shanghai MAaGI Medical Technology Co., Ltd.)	These patients will receive multimodal thermal therapy using Multimodal Tumor Thermal Therapy System.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-03-07
• Completion: 2026-10-07
• First posted: 2024-10-10
• Last updated: 2024-10-10

Locations

1 site across 1 country: China