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Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology

2017年4月25日更新者：Real Imaging Ltd.

The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

研究概览

地位

撤销

条件

乳腺癌

详细说明

The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

以色列
- - Jerusalem、以色列
    - Hadassah Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Subjects arriving for a mammography or breast ultrasound

描述

Inclusion Criteria:

Gender: female
Age: 50 years and older
Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
Subject who have signed an informed consent form.

Exclusion Criteria:

Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager.
Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
Subjects who have undergone a mastectomy.
Subjects who have undergone a lumpectomy.
Subjects who have a large scar (causing breast deformation).
Subjects who have previously undergone or are currently undergoing breast radiation therapy.
Subjects who have previously undergone or are currently undergoing chemotherapy.
Subjects with prior breast reduction surgery or breast augmentation surgery.
Subjects who are pregnant.
Subjects who are breast-feeding.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Real Imaging Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2015年5月1日

初级完成 (预期的)

2016年5月1日

研究完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2009年12月9日

首先提交符合 QC 标准的