Dual-layer spectral computerized tomography for breast cancer detection in women with dense breasts: a single centre, feasibility study.
- Conditions
- 10006232Mammary cancer10006291
- Registration Number
- NL-OMON50792
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
1. Females aged 18 years and over
2. Diagnosis of histopathologically proven locoregional advanced primary breast
cancer:
- A. Tumors > 5 cm (= T3) or
- B. Tumors with invasion of the skin or chest wall (= T4) or
- C. Any tumor with >= 4 axillary lymph nodes or ipsilateral internal mammary,
infraclavicular or supraclavicular nodal involvement (= N2-3)
3. Heterogeneously or extremely dense breasts on full-field digital mammograms:
category C or D according to the ACR BI-RADS lexicon
1. History of allergic reactions to iodinated contrast agents
2. Pregnancy or breast feeding
3. Treatment of thyroid disease with radioactive iodine
4. Use of metformin
5. Creatinine clearance < 45 ml/min
6. Chronic or acutely worsening renal disease
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the feasibility of DLSCT to detect breast cancer in women with<br /><br>dense breasts and histopathologically locoregional advanced primary breast<br /><br>cancer.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To determine iodine enhancement (HU) and iodine content (mg/mL) values of<br />tumor, normal breast tissue and pectoralis muscle in reconstructed virtual<br />monochromatic images obtained at 40, 60, 80 and 100 keV and iodine maps<br />2. To correlate tumor conspicuity and BI-RADS score with the following<br />features: size of tumor, type of tumor, MRI and PET-CT images, histologic<br />gradation of tumor and immunohistochemical staining results</p>