DECREAS: DLSCT for Breast Cancer Detection in Women With Dense Breasts
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- Iodine enhancement [On the same 1 day as the regular PET-CT scan was performed]
Iodine enhancement will be measured in Hounsfield Units (HU).
- Iodine content [On the same 1 day as the regular PET-CT scan was performed]
Iodine content will be measured mg/mL.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
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Tumors > 5 cm (= T3) or
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Tumors with invasion of the skin or chest wall (= T4) or
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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:
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History of allergic reactions to iodinated contrast agents
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Pregnancy or breast feeding
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Treatment of thyroid disease with radioactive iodine
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Use of metformin
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Creatinine clearance < 45 ml/min
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Chronic or acutely worsening renal disease
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Patients who are declared incompetent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rijnstate Hospital | Arnhem | Netherlands |
Sponsors and Collaborators
- Rijnstate Hospital
Investigators
- Principal Investigator: Laura N Deden, Rijnstate Hospital
- Principal Investigator: Maxime V.P. Schyns, MD, Rijnstate Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL76792.091.21