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MRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer.


- candidate number13343
- NTR NumberNTR3624
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-sep-2012
- Secondary IDsNL39519.041.12 / 12-082  CCMO
- Public TitleMRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer.
- Scientific TitleMRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedBreast cancer, MRI-guided High-Intensity Focused Ultrasound Ablation
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-sep-2012
- planned closingdate1-dec-2013
- Target number of participants10
- InterventionsIntervention 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.
- Primary outcomeThe 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 outcomeThe secondary objective of this feasibility study is to determine safety of MR-HIFU in breast cancer patients using a dedicated MR-HIFU breast system.
- TimepointsMRI scan and HIFU treatment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Laura Merckel
- CONTACT for SCIENTIFIC QUERIESMD. Laura Merckel
- Sponsor/Initiator University Medical Center Utrecht, Department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
Center for Translational Molecular Medicine (CTMM)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-sep-2012 - 27-sep-2012


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