DLSCT for Breast Cancer Detection in Women With Dense Breasts

Study Overview
=================
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.

Official Title
-----------------
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study

Conditions
-----------------
Breast Density, Breast Neoplasms, Radiographic Image Interpretation, Computer-Assisted

Intervention / Treatment
-----------------
* Diagnostic Test: Dual-layer spectral computerized tomography (DLSCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of histopathologically proven locoregional advanced primary breast cancer: Tumors > 5 cm (= T3) or Tumors with invasion of the skin or chest wall (= T4) or 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Dual-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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual tumor conspicuity | The conspicuity of tumors will be graded on a 4-point confidence scale | On the same 1 day as the regular PET-CT scan was performed | 
| BI-RADS score | BI-RADS score according to the ACR BI-RADS lexicon | On the same 1 day as the regular PET-CT scan was performed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iodine enhancement | Iodine enhancement will be measured in Hounsfield Units (HU). | On the same 1 day as the regular PET-CT scan was performed | 
| Iodine content | Iodine content will be measured mg/mL. | On the same 1 day as the regular PET-CT scan was performed |