Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-10-31

Brief Summary

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Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot objects in the body. When it comes to the breast, causes of deep structure hot spots are numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective of this study is to test the sensitivity of the Medical Radiometer in detecting the hot spots in the breast.

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Detailed Description

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Several pathological lesions and physiological changes can cause spot in the breast to show higher temperature than it should be.

The causes can be:

\[I\] Physiological: During menarch, puberty, menstruation, lactation and after sexual Intercourse.

\[II\] Inflammatory: Mastitis and breast Abscess. \[III\] Endocrinal: any cause of increasing Oestrogen, Prolactin and/or Thyroid hormones.

\[IV\] Neoplastic: the neo-Vascularisation of the malignant tumors. Radiometer is a machine that can detect through its sensitive probe the microwave that radiate from the deep structures in the body.

The main aim of this study, first is to measure the sensitivity of the RTM in detecting the hot spots of different breast lesions.

The second Objective is to study the temperature patter of each disease trying to figure out a diagnostic code for the different lesions.

The tertiary objective is to combine the Echo-Dobbler in studying the hot spots in the neoplastic lesions trying to figure out an accurate protocol to early detect the malignant hot spots.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Microwave Thermography RTM-01-RES

Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues

Group Type NO_INTERVENTION

Microwave Thermography RTM-01-RES

Intervention Type DEVICE

Divide the breast into 3 circles start from the nipple with 1 cm increase in the circle diameter. Divide this circle into 8 points. This makes us detect 24 points in addition to the nipple as fixed point and the tail of the breast as separate point giving total of 26 points.

Interventions

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Microwave Thermography RTM-01-RES

Divide the breast into 3 circles start from the nipple with 1 cm increase in the circle diameter. Divide this circle into 8 points. This makes us detect 24 points in addition to the nipple as fixed point and the tail of the breast as separate point giving total of 26 points.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The perfect sample should be 2000 females or more.
* 50 % already diagnosed breast cancer of any type
* 30% normal thought to be healthy females.
* 10% lactating
* 10% different breast diseases