For women with breast implants, screening for breast cancer with x-ray mammography suffers a major drawback since the implant obscures the breast tissue behind it. In addition, the pressure applied to the breast during mammography may rapture or damage the implant. Ultrasound is offered as an alternative which is sub-optimal due to low specificity.
The purpose of this study is to evaluate the ability of 3D MIRA technology to correctly classify breast cancer likelihood in women with breast implants. In previous studies, women who had breast augmentation were not included. This is the first study which focuses on this population. By acquiring images from women with implants, both healthy and newly diagnosed breast cancer patients, the sensitivity and specificity of 3D MIRA technology will be tested.
A minimum of 200 women with breast implants are expected to participate in this trial.
Information on additional planned trials is forthcoming
The aim of this study is to evaluate the performance of 3D MIRA technology in correctly classifying women with breast cancer, and to determine whether standard care imaging modalities (mammography, ultrasound) plus 3D MIRA imaging will improve breast cancer detection rate.
Subjects for this trial are women at high risk for breast cancer, mainly carriers of BRCA1/BRCA2 genes. Participants will be screened using the excepted modalities (mammography, ultrasound) in addition to their assessment with 3D MIRA.
If assessed as suspicious for cancer, the subject would be referred to MRI for confirmation of suspicious finding, even if she was found negative in mammography and/or ultrasound exam.
This is a longitudinal study, in which each participant will be assessed every 6 month for the course of 3 years. This will allow evaluating whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer, so that preventative measures could be applied individually to women with high likelihood.
Real imaging has launched a study to assess the performance of 3D MIRA technology in women at high risk for breast cancer. The study is conducted in collaboration with the Karolinska Institute in one of the major hospitals in Sweden.
The purpose of this clinical study is to assess the ability of 3D MIRA technology to detect clinically occult breast cancer in a cohort of women with dense breasts and/or high Tyrer- Cuzick score, a statistical test used to assess the life-time risk for breast cancer.
The Karolinska Institute is conducting the Swedish national breast cancer study (karmastudy.org). The collaboration enables access to one of the world's best characterized breast cancer cohorts, hence allowing high recruitment rate of women determined to have a high risk of breast cancer based on breast density and/or Tyrer-Cuzick risk model.
Participants in the study are screened for breast cancer using the excepted modalities (mammography, ultrasound) in addition to their assessment with 3D MIRA technology. If assessed as. suspicious for cancer, the subject is referred to MRI for confirmation of suspicious finding, even if she was found negative in mammography and/or ultrasound exams.
The main study hypothesis is that the combination of mammography and 3D MIRA screening will result in significantly higher breast cancer detection rates in women with dense breast tissue or high risk for breast cancer.