An observational study in Breast Neoplasms, Breast Density and Radiographic Image Interpretation, Computer-Assisted, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by Rijnstate Hospital · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 14 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
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Secondary care clinic
Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
Exclusion Criteria:
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.
Visual tumor conspicuity
The conspicuity of tumors will be graded on a 4-point confidence scale
Time frame: 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
Time frame: On the same 1 day as the regular PET-CT scan was performed
Iodine enhancement
Iodine enhancement will be measured in Hounsfield Units (HU).
Time frame: On the same 1 day as the regular PET-CT scan was performed
Iodine content
Iodine content will be measured mg/mL.
Time frame: On the same 1 day as the regular PET-CT scan was performed
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Rijnstate Hospital