DLSCT for Breast Cancer Detection in Women With Dense Breasts

Rijnstate Hospital14 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Neoplasms Breast Density Radiographic Image Interpretation, Computer-Assisted

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual tumor conspicuity

The conspicuity of tumors will be graded on a 4-point confidence scale

Time frame: 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

Time frame: On the same 1 day as the regular PET-CT scan was performed

Secondary Outcomes

Iodine enhancement

Iodine enhancement will be measured in Hounsfield Units (HU).

Time frame: On the same 1 day as the regular PET-CT scan was performed

Iodine content

Iodine content will be measured mg/mL.

Time frame: On the same 1 day as the regular PET-CT scan was performed

DLSCT for Breast Cancer Detection in Women With Dense Breasts

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts