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

Labdom Suisse

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Microwave Thermography RTM-01-RES

Study type: Interventional

Funder types: Other

Identifiers

NCT02286583

LabdomSuisseRD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Microwave Thermography RTM-01-RES

No Intervention group

Description:

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

Treatment:

Device: Microwave Thermography RTM-01-RES