Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis
Terminated
- Conditions
- Breast Screening
- Registration Number
- NCT03929822
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
- Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.
Exclusion Criteria
- Age <30 years old
- Screening mammography with only calcifications abnormalities
- Male patients
- Pregnant or lactating patients
- Patients with any allergy to iodinated contrast
- Patients with eGFR < 45
- Patients that may be treated with radioactive iodine
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of CESM compared to mammography 2 years The radiologist will interpret the low energy images and record their findings.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie contrast-enhanced spectral mammography's ability to improve diagnostic accuracy in breast screening?
How does contrast-enhanced spectral mammography compare to MRI and ultrasound in reducing unnecessary biopsies for breast cancer detection?
Which biomarkers are associated with improved diagnostic outcomes using contrast-enhanced spectral mammography in breast screening?
What adverse events are reported with contrast-enhanced spectral mammography and how are they managed in clinical practice?
Are there combination approaches involving contrast-enhanced spectral mammography and other imaging modalities for enhanced breast cancer screening?
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center🇺🇸New York, New York, United States