DLSCT for Breast Cancer Detection in Women With Dense Breasts

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

• Registration Number: NCT05181059
• Lead Sponsor: Rijnstate Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BI-RADS score	On the same 1 day as the regular PET-CT scan was performed	BI-RADS score according to the ACR BI-RADS lexicon
Visual tumor conspicuity	On the same 1 day as the regular PET-CT scan was performed	The conspicuity of tumors will be graded on a 4-point confidence scale

Secondary Outcome Measures

Name	Time	Method
Iodine content	On the same 1 day as the regular PET-CT scan was performed	Iodine content will be measured mg/mL.
Iodine enhancement	On the same 1 day as the regular PET-CT scan was performed	Iodine enhancement will be measured in Hounsfield Units (HU).

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands