Reduced contrast administration in contrast-enhanced spectral mammography (CESM)
Phase 4
Completed
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON45266
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
1. Female patient with histopathogically confirmed invasive breast cancer who recently underwent a clinical CESM exam without complications;
2. Treated with primary surgery;
3. Willing and able to undergo all study procedures;
4. Has personally provided written informed consent.
5. Age * 18
Exclusion Criteria
1. Pregnancy
2. Allergy for any of the ingredients of (Ultravist) contrast agent
3. Being unable to give informed consent in person
4. History of coronary arterial disease or unstable angina
5. Acute or chronic severe renal insufficiency (glomerular filtration rate < 45 mL/min/1.732)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All exams will be reviewed by two expert CESM radiologists, blinded for<br /><br>contrast dose used, final tumor pathology and extent, and each other*s results.<br /><br>The primary study parameter will be assessed for both the clinical and reduced<br /><br>CESM exam and will consist of maximum tumor diameter. Final tumor pathology<br /><br>results as assessed on the surgical specimen will serve as the gold standard. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Enhancement measurements for breast cancer detected with the clinical CESM exam<br /><br>(reference) compared to the (experimental) CESM exams with varying (lower) dose<br /><br>concentrations.</p><br>