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

Study Overview
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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.

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.

Official Title
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Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Microwave Thermography RTM-01-RES


Participation Criteria
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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 Exclusion Criteria: Menstruating females.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Microwave Thermography RTM-01-RES<br>Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues | Device: Microwave Thermography RTM-01-RES<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions) | Ability of the Microwave Thermography RTM-01-RES to detect hotspots in the various breast lesions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the Temperature pattern | The temperature pattern of previously diagnosed diseases and the new healthy objects might give us an idea about whether we can diagnose various breast diseases or no. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RTM, Female breast cancer