Breast Density, Breast Neoplasms, Radiographic Image Interpretation, Computer-Assisted
Conditions
Brief summary
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts. Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
Interventions
DIAGNOSTIC_TESTDual-layer spectral computerized tomography (DLSCT)
Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.
Sponsors
Rijnstate Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Diagnosis of histopathologically proven locoregional advanced primary breast cancer: 1. Tumors \> 5 cm (= T3) or 2. Tumors with invasion of the skin or chest wall (= T4) or 3. Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3) * Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Exclusion criteria
* History of allergic reactions to iodinated contrast agents * Pregnancy or breast feeding * Treatment of thyroid disease with radioactive iodine * Use of metformin * Creatinine clearance \< 45 ml/min * Chronic or acutely worsening renal disease * Patients who are declared incompetent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual tumor conspicuity | On the same 1 day as the regular PET-CT scan was performed | The conspicuity of tumors will be graded on a 4-point confidence scale |
| BI-RADS score | On the same 1 day as the regular PET-CT scan was performed | BI-RADS score according to the ACR BI-RADS lexicon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iodine enhancement | On the same 1 day as the regular PET-CT scan was performed | Iodine enhancement will be measured in Hounsfield Units (HU). |
| Iodine content | On the same 1 day as the regular PET-CT scan was performed | Iodine content will be measured mg/mL. |
Countries
Netherlands
Contacts
Primary ContactCarla M Meeuwis, MD,PhD
Outcome results
None listed