N/A
ID
Bron
Aandoening
Breast cancer, MRI-guided High-Intensity Focused Ultrasound Ablation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksopzet
MRI scan and HIFU treatment.
Onderzoeksproduct en/of interventie
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.
Publiek
University Medical Center Utrecht<br>
Heidelberglaan 100
Laura Merckel
Utrecht 3584 CX
The Netherlands
+31 (0)88 7550286
L.G.Merckel-2@umcutrecht.nl
Wetenschappelijk
University Medical Center Utrecht<br>
Heidelberglaan 100
Laura Merckel
Utrecht 3584 CX
The Netherlands
+31 (0)88 7550286
L.G.Merckel-2@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3472 |
| NTR-old | NTR3624 |
| CCMO | NL39519.041.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39336 |