DLSCT for Breast Cancer Detection in Women With Dense Breasts

Breast Neoplasms Clinical Trial

— DECREAS  

Official title:

Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181059
• Other study ID #: NL76792.091.21
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2022
• Source: Rijnstate Hospital
• Contact: Carla M Meeuwis, MD,PhD
• Phone: +31 26 378 8888
• Email: cmeeuwis[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Density
• Breast Neoplasms

Intervention

Diagnostic Test:
• Dual-layer spectral computerized tomography (DLSCT)
Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual tumor conspicuity	The conspicuity of tumors will be graded on a 4-point confidence scale	On the same 1 day as the regular PET-CT scan was performed
Primary	BI-RADS score	BI-RADS score according to the ACR BI-RADS lexicon	On the same 1 day as the regular PET-CT scan was performed
Secondary	Iodine enhancement	Iodine enhancement will be measured in Hounsfield Units (HU).	On the same 1 day as the regular PET-CT scan was performed
Secondary	Iodine content	Iodine content will be measured mg/mL.	On the same 1 day as the regular PET-CT scan was performed