MIRA™ - Principles

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Products

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> Clinical Studies
> Concluded Studies
Ongoing Studies
Future Studies

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Concluded Studies

Real Imaging has partnered with leading hospitals in Israel to conduct clinical studies and is planning to launch international clinical studies during 2010.

All studies are conducted with prototypes of RUTH at different stages of R&D.

RI1.X	Single optical head
RI2.X	Single optic head, aperture adjustment
RI3.X	Single optic head, hardware based syncronization
RI4.X	Dual optic 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 tumors

• 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 accordingly reach decisions about the nature and directions of the development of a new three-dimensional IR body modeling device which will assist in early detection of breast cancerous tumors.
• Study Population: women aged 20-75, who regardless of the clinical study, are summoned for a routine breast screening examination (mammography and/or US).
• Investigational Device: RI1.X*
• Study Design: Acquiring 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
• Principal Investigator: Dr. Miri Sklair-Levy
• Conclusions:
  • Promising preliminary results
  • Cold Stress Challenge (CSC) can assist in the detection of breast cancer

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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 Objectives: to enlarge and improve the database of IR images designated for algorithm R&D and to examine the effect of Cold Stress Challenge (CSC) on the IR images of women with findings of different types and severities
• Study Population: women aged 18 years or older, who regardless of the clinical study, are summoned for a diagnostic breast examination after a suspicious breast lesion has been identified by mammography and/or ultrasound and/or MRI and/or physical examination.
• Investigational Device: RI2.X*
• Study Design: Acquiring raw data of IR and visual images of the left and right breasts, simultaneously in a pre-defined imaging procedure which includes CSC.
• Number of subjects enrolled: 106
• Duration: May 2008 - October 2008
• Study Site: Hadassah Medical Center
• Principal Investigator: Dr. Miri Sklair-Levy
• Conclusions:
  • Extremely promising results showing the technology's both sensitive and specific nature.
  • The future product must include two optical heads which will enable imaging the side of the breast's and the axilla.

Read the study Whitepaper

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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 Objectives: to evaluate and improve Real Imaging's device which will assist in early detection of breast cancer. At the current stage of the development of the device, the goal of this clinical study is in no way to arrive at a statistical analysis. The first phase of the study is non-blinded and is aimed at algorithm calibration and fine-tuning. The second phase of the study is a blinded phase for statistical analysis.
• Study Population: women aged 18 years or older, who regardless of the clinical study, are summoned for a breast biopsy.
• Investigational Device: RI3.X*
• Study Design: Acquiring raw data of IR and visual images of the left and right breasts, simultaneously in a pre-defined imaging procedure which includes CSC.
• Number of subjects enrolled: 575
• Duration: December 2008 - July 2009
• Study Sites and Principal Investigators:
  Hadassah Medical Center, Israel - Dr. Tamar Sela
  Beilinson Medical Center, Israel - Dr. Maya Cohen
  Lin Medical Center, Israel - Dr. Mariana Steiner
  Meir Medical Center, Israel - Dr. Myra Shapiro
• Conclusions: Data collected until just recently is being processed. Results and conclusions are not available yet.

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* RUTH R&D prototypeRUTH™ - Not available for sale in the US