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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05181059
Other study ID # NL76792.091.21
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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