Breast Carcinoma Clinical Trial
Official title:
Diagosis of Breast Carcinoma: Characterization of Breast Lesions With CLEARPEMSONIC : Feasibility Study
Breast cancer is the first cancer in women, the second etiology of death by cancer and the
first cause for women between 35 and 55 years.
Diagnostic tools and large screening have been realized with positive impact in a recent
review with 31% less likely to die of breast cancer over nearly 30 years compared to women
who didn't get regular screening mammograms. Diagnostic tools and treatment also are
improving continuously.
However, for some women, breast cancer diagnosis is difficult, in case of high density
breast, breast modifications after surgery… In these cases, breast MRI is currently the best
imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that
lead to futile biopsies.
Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify
cancer treatment.
However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor
because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET
scan for breast, called Positron Emission Mammography. Our project is in this field of view
and is named CLEARPEMSONIC.
First clinical studies with PEM showed very good performance of this imaging modality for
initial evaluation of breast tumors. PEM performance is not affected by breast density,
hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI,
adding a better specificity value.
In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which
combined PEM scan and ultrasonography.
Technologic evaluation was made. Now a feasibility study is the first step for clinical
applications.
The main objective of this project is to confirm the feasibility of PEM scan with the
ClearPEmSonic.
Secondary objectives are to compare results with other conventional imaging modalities and
MRI.
The gold standard will be histology of the breast tumor.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
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