No registrations found.
ID
Source
Health condition
Breast cancer, MRI-guided High-Intensity Focused Ultrasound Ablation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of this feasibility study is to determine treatment accuracy of MR-HIFU in breast cancer patients using a dedicated MR-HIFU breast system.
Secondary outcome
The secondary objective of this feasibility study is to determine safety of MR-HIFU in breast cancer patients using a dedicated MR-HIFU breast system.
Background summary
N/A
Study objective
N/A
Study design
MRI scan and HIFU treatment.
Intervention
Intervention with MR-HIFU:
HIFU uses focused ultrasound waves to heat and thermally ablate tissue. In this study only a part of the breast tumor will be ablated. The MRI system identifies the ultrasound path and monitors heat rise in the breast tissue and the surrounding structures.
University Medical Center Utrecht<br>
Heidelberglaan 100
Laura Merckel
Utrecht 3584 CX
The Netherlands
+31 (0)88 7550286
L.G.Merckel-2@umcutrecht.nl
University Medical Center Utrecht<br>
Heidelberglaan 100
Laura Merckel
Utrecht 3584 CX
The Netherlands
+31 (0)88 7550286
L.G.Merckel-2@umcutrecht.nl
Inclusion criteria
1. Female aged 18 years and over;
2. Able to give informed consent herself;
3. World Health Organization performance score ≤ 2;
4. Weight < 80 kg;
5. The target breast fits into the cup of the dedicated MR-HIFU breast system;
6. Patients with cT1-2 (≥1.0 cm) invasive breast cancer, confirmed by histopathology;
7. Size of the tumor is determined on mammography or ultrasound.
Exclusion criteria
1. Patients treated with neo-adjuvant systemic therapy;
2. Contra-indications for MRI scanning according to the hospital guidelines;
3. Contra-indications to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR < 30mL/min/1.73m2;
4. Macro calcifications around the targeted tumor;
5. Scar tissue or surgical clips in the direct path of the HIFU beam;
6. Pregnant or lactating women;
7. Patients who don't want to be informed about unexpected findings on MRI.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3472 |
| NTR-old | NTR3624 |
| CCMO | NL39519.041.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39336 |