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Clinical Trials/2024-518549-27-00
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

Sponsor
Radboud universitair medisch centrum Stichting
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Stichting Radboud University Medical Center

Scientific

Radboud universitair medisch centrum Stichting

Study Sites (1)

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