DLSCT for Breast Cancer Detection in Women With Dense Breasts (DECREAS)

Rijnstate Hospital

Status: Unknown

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

Treatments: Diagnostic Test: Dual-layer spectral computerized tomography (DLSCT)

Study type: Observational

Funder types: Other

Identifiers

NCT05181059

NL76792.091.21

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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