NL-OMON39336CompletedPhase 2
MRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer - MR-HIFU of breast cancer
niversitair Medisch Centrum Utrecht0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Female aged 18 years and over
- •Able to give informed consent herself
- •World Health Organization performance score <= 2
- •Weight < 80 kg
- •The target breast fits into the cup of the dedicated MR-HIFU breast system
- •Patients with cT1-2(>= 1.0 cm) invasive breast cancer, confirmed by histopathology. Size of the tumor is determined on mammography or ultrasound
Exclusion Criteria
- •Patients treated with neo-adjuvant systemic therapy
- •Contra-indications for MRI scanning according to the hospital guidelines
- •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
- •Macro calcifications around the targeted tumor
- •Scar tissue or surgical clips in the direct path of the HIFU beam
- •Pregnant or lactating women
- •Patients who don*t want to be informed about unexpected findings on MRI
Investigators
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