Breast Cancer Clinical Trial
Official title:
Added Value of Contrast Enhanced Spectral Mammography, CESM in Diagnostics and Size Estimation of Malignant Lesions in Breast. A Pilot Study.
Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of
malignant lesions in breast is required. Sometimes a supplementary MRI is therefore
recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral
mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity
and specificity. Size assessment using contrast-based modalities as CESM has also been shown
to be significantly more accurate than using mammography. Prospective randomized studies
using CESM are lacking.
Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast
cancer and choice of operation; partial mastectomy or mastectomy.
A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized
study.
Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and
core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A
supplementary examination with CESM will be performed. Preoperative extent of the malignant
lesions are estimated with each modality and is later compared with the extent measured in
post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT
or endocrine therapy, breast volume and density is collected, as well as data of diagnosis
(ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression
and Ki67 index.
In this pilot study sensitivity and specificity for each modality is calculated. Multivariate
analysis will be performed regarding influential factors. Pearson correlation coefficient
will be calculated for each modality regarding size assessment of the malignant lesions in
comparison with definitive PAD.
n/a
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