Trials / Withdrawn
WithdrawnNCT02407613
Efficacy of MR-HIFU Ablation of Breast Cancer
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Philips Sonalleve MR-HIFU Breast Tumor Therapy System | Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2015-04-03
- Last updated
- 2024-05-21
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02407613. Inclusion in this directory is not an endorsement.