2024-518549-27-00RecruitingPhase 4
Efficacy of Reduced Gadolinium Dose in Contrast-Enhanced Breast MRI
Radboud universitair medisch centrum Stichting1 site in 1 country100 target enrollmentStarted: February 20, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Qualitative Evaluation of image quality
Study Overview
Brief Summary
To evaluate whether AI-enhanced low-dose gadolinium contrast-enhanced breast MRI achieves diagnostic image quality equivalent to standard-of-care-dose breast MRI
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult women ( > 18 years old) that are scheduled to undergo contrast-enhanced breast MRI
Exclusion Criteria
- •Women under 18 years old
- •Individuals not scheduled for contrast-enhanced breast MRI
- •Pregnant or breastfeeding women
- •Individuals with contraindications to MRI (e.g., pacemakers, metal implants) and claustrophobia
- •Patients with renal insufficiency (eGFR < 30 ml/min/1.73m2)
- •Patients on hemodialysis or peritoneal dialysis
- •Patients with known allergic reactions to GBCAs
- •Male subjects
- •Women who cannot give informed consent
Outcomes
Primary Outcomes
Qualitative Evaluation of image quality
Qualitative Evaluation of image quality
Quantitative Evaluation of image quality
Quantitative Evaluation of image quality
Secondary Outcomes
- Diagnostic performance
Investigators
Stichting Radboud University Medical Center
Scientific
Radboud universitair medisch centrum Stichting
Study Sites (1)
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