Imaging of breast cancer using CT (“DECREAS-2 study”)

Contrast-enhanceD Multi-Energy Computerized tomography for bREASt cancer staging: a multicenter, feasibility study - Contrast-enhanced multi-energy CT for breast cancer staging in women with dense breasts

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58652

Enrollment

Registered

2025-12-08

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Breast cancer Breast cancer

Interventions

Siemens Photon-Counting CT scannerSiemens Dual-source CT scannerSiemens Twin-spiral CT scannerPhilips IQon spectral CT scannerSiemens MRI scanner (as a comparison with CT, this scan is part of standar

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must have given written informed consentFemales aged 18 years and overDiagnosis of histopathologically proven primary breast cancerHeterogeneously dense (category C) or extremely dense (category D) breasts on full-field digital mammography, as defined by the ACR BI-RADS lexicon

Exclusion criteria

Exclusion criteria: CT-related contraindications, among which:History of allergic reactions to iodinated contrast agentsPregnancy or breast feedingRecent treatment (<8 weeks ago) of thyroid disease with radioactive iodineUse of metforminCreatinine clearance < 45 mL/minChronic or acutely worsening renal diseaseOther contraindications:Patients who are declared incompetent

Design outcomes

Primary

Measure	Time frame
On multi-energy CT, the breast lesions will be compared to surrounding tissues in terms of iodine uptake, normalized iodine uptake and spectral slope between 40 and 70 keV. The qualitative assessment will be done by three breast radiologists who will identify the breast lesions and rate the amount of background enhancement on multi-energy CT and compare it to DCE-MRI	—

Secondary

Measure	Time frame
To analyze radiation exposure of each multi-energy CT scan. Effective dose will be estimated using: o Effective dose (mSv) = DLP (mGycm) * conversion factor for the chest (mSv/mGycm) The CTDIvol will be used to calculate the DLP and the conversion factor for the chest is 0.0145 mSv/mGycmTo assess patient experience using a visual analog scale (VAS) score for different modalities, including mammography, DCE-MRI, and contrast-enhanced multi-energy CT.	—

Measure

Time frame

To analyze radiation exposure of each multi-energy CT scan. Effective dose will be estimated using: o Effective dose (mSv) = DLP (mGycm) * conversion factor for the chest (mSv/mGycm) The CTDIvol will be used to calculate the DLP and the conversion factor for the chest is 0.0145 mSv/mGycmTo assess patient experience using a visual analog scale (VAS) score for different modalities, including mammography, DCE-MRI, and contrast-enhanced multi-energy CT.

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Countries

Netherlands

Contacts

Public ContactR.J.A. Duteweert

Rijnstate

rduteweert@rijnstate.nl088-0057795

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026