Clinical trial · Observational
DLSCT for Breast Cancer Detection in Women With Dense Breasts
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Density | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiographic Image Interpretation, Computer-Assisted | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual-layer spectral computerized tomography (DLSCT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Visual tumor conspicuity
- timeFrame
- On the same 1 day as the regular PET-CT scan was performed
- description
- The conspicuity of tumors will be graded on a 4-point confidence scale
- measure
- BI-RADS score
- timeFrame
- On the same 1 day as the regular PET-CT scan was performed
- description
- BI-RADS score according to the ACR BI-RADS lexicon
Secondary outcomes (2)
- measure
- Iodine enhancement
- timeFrame
- On the same 1 day as the regular PET-CT scan was performed
- description
- Iodine enhancement will be measured in Hounsfield Units (HU).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available