Dual-layer spectral computerized tomography for breast cancer detection in women with dense breasts: a single centre, feasibility study.

Dual-layer spectral computerized tomography for breast cancer detection in women with dense breasts: a single centre, feasibility study. - The DECREAS study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50792

Enrollment

Registered

2021-08-05

Start date

2023-02-15

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammary cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To determine the feasibility of DLSCT to detect breast cancer in women with dense breasts and histopathologically locoregional advanced primary breast cancer.	—

Secondary

Measure	Time frame
1. To determine iodine enhancement (HU) and iodine content (mg/mL) values of tumor, normal breast tissue and pectoralis muscle in reconstructed virtual monochromatic images obtained at 40, 60, 80 and 100 keV and iodine maps 2. To correlate tumor conspicuity and BI-RADS score with the following features: size of tumor, type of tumor, MRI and PET-CT images, histologic gradation of tumor and immunohistochemical staining results	—

Measure

Time frame

1. To determine iodine enhancement (HU) and iodine content (mg/mL) values of tumor, normal breast tissue and pectoralis muscle in reconstructed virtual monochromatic images obtained at 40, 60, 80 and 100 keV and iodine maps 2. To correlate tumor conspicuity and BI-RADS score with the following features: size of tumor, type of tumor, MRI and PET-CT images, histologic gradation of tumor and immunohistochemical staining results

—

Countries

Netherlands

Outcome results