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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-layer spectral computerized tomography (DLSCT) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Iodine enhancement | Iodine enhancement will be measured in Hounsfield Units (HU). | On the same 1 day as the regular PET-CT scan was performed |
| Iodine content | Iodine content will be measured mg/mL. |
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Inclusion Criteria:
Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
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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Secondary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla M Meeuwis, MD,PhD | Contact | +31 26 378 8888 | cmeeuwis@rijnstate.nl |
| Name | Affiliation | Role |
|---|---|---|
| Laura N Deden | Rijnstate Hospital | Principal Investigator |
| Maxime V.P. Schyns, MD | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Recruiting | Arnhem | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| On the same 1 day as the regular PET-CT scan was performed |
| D017437 |
| Skin and Connective Tissue Diseases |