Concluded Studies

Real Imaging has partnered with leading hospitals in Israel to conduct clinical studies and is planning to launch its first international clinical study at the end of 2011.

All studies used prototypes of the RUTH (RI1, RI2, RI3, RI4) system, as explained below, at different stages of research and development, integrated with MIRA™ technology.

RI1	Single optical head
RI2	Single optical head, aperture adjustment
RI3	Single optical head, hardware based syncronization
RI4	Dual optical head

1 Concluded studies

1.1 Protocol #Thermo001: Collection of initial raw data of IR imaging for the purpose of developing a device for early diagnosis of breast cancer.

• Study Objective: Collection of IR images of healthy women and women with breast cancer tumors in varying degrees of severity in order to evaluate the raw data and reach decisions accordingly about the nature and direction of the development of a new 3D IR imaging device which will assist in the early detection of breast cancer.
• Study Population: Women aged 20-75, summoned for a routine breast screening examination (mammography and/or US).
• Investigational Device: RI1 MIRA™ technology
• Study Design: To acquire raw data of IR and visual images of the left and right breasts, separately.
• Number of subjects enrolled: 45
• Duration: November 2007 - February 2008
• Study Site: Hadassah Medical Center - Israel
• Principal Investigator: Dr. Miri Sklair-Levy
• Conclusions:
  • Promising preliminary results
  • Further development of MIRA™ technology to allow imaging both sides of the breasts simultaneously.

1.2 Protocol #108-8051: Collection of primary raw data of IR imaging for the development of a medical device intended for early diagnosis of breast cancer

• Study Objective: To increase and improve the database of IR images designated for algorithm research and development with findings of different types and severities of breast cancer.
• Study Population: Women aged 18 years or older, summoned for a diagnostic breast examination after a suspicious breast finding was identified by mammography and/or ultrasound and/or MRI and/or physical examination.
• Investigational Device: RI2. MIRA™ technology
• Study Design: To acquire raw data of IR and visual images of the right and left breasts simultaneously, in a pre-defined imaging procedure.
• Number of subjects enrolled: 106
• Duration: May 2008 - October 2008
• Study Site: Hadassah Medical Center - Israel
• Principal Investigator:
  Dr. Miri Sklair-Levy
• Conclusions:
  • Preliminary results suggest that MIRA™ technology imaging has both high sensitivity for the detection of breast pathology and high specificity. This indicates possible use as an adjunct device with conventional diagnostic breast imaging. Furthermore, since MIRA™ technology involves a non-contact, radiation-free scan followed by quantitative analysis of the recorded signals, the results obtained using MIRA™ technology can be easily integrated in the patient’s diagnosis process.
  • Future MIRA™ technology should include a dual optical head to also enable the imaging of both sides of the breasts.

1.3 Protocol #Pr-118-8061: Collection of raw data of IR imaging for the purpose of developing a device for early detection of breast cancer.

• Study Objective: To evaluate and improve Real Imaging's functional automatic system which will assist in the early detection of breast cancer
• Study Population: Women aged 18 years or older, who are summoned for a breast biopsy. In this study a control group was also used that included women with no breast findings but had been summoned for an annual screening examination
• Investigational Device: RI3 MIRA™ technology
• Study Design: Acquiring raw data of IR and visual images of the right and left breasts simultaneously. In the first stage of the analysis a training group was used using an algorithm parameters calibration (a mathematical model using pre existing results). The second stage used a test group consisting of blinded images (no clinical data beforehand) towards a statistical analysis.
• Number of subjects enrolled: 667
• Duration: December 2008 - July 2009
• Study Sites and Principal Investigators:
  Dr. Tamar Sela - Hadassah Medical Center, Israel
  Dr. Maya Cohen - Beilinson Medical Center, Israel
  Dr. Mariana Steiner - Lin Medical Center, Israel
  Dr. Myra Shapiro - Meir Medical Center, Israel
• Results: The analysis was performed on 2 sets of women, randomly selected - a training (calibration) set and a test (blinded) set with the following distribution:
  ° The training set included 74 women – 43 were found to have abnormal findings and 31 with no breast findings at all.
  ° The test set included 100 women – 39 had abnormal findings and 61 with no breast findings at all.
  ° All the other women in this study, with benign findings were not included in the analysis.
  The sensitivity and specificity of the test set can be seen in the ROC curve, Fig. 1 below.
  
  Fig.1 click here to enlarge
  
  
• Conclusions:
  • MIRA™ technology has a very high potential to serve as an adjunct device for the identification and diagnosis of breast cancer.
  • Further development of a device with a dual optical head to allow a panoramic image of the breast including both sides of the breast.