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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Microwave Thermography RTM-01-RES

• Registration Number: NCT02286583
• Lead Sponsor: Labdom Suisse

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-18
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-10
• Study Start: 2015-02
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01
• Primary Completion: 2015-05
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microwave Thermography RTM-01-RES	Microwave Thermography RTM-01-RES	Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues

Primary Outcome Measures

Name	Time	Method
Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)	6 months	Ability of the Microwave Thermography RTM-01-RES to detect hotspots in the various breast lesions.

Secondary Outcome Measures

Name	Time	Method
Study the Temperature pattern	3 months	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.

Trial Locations

Locations (1)

Poliklinik Permai Tanjumg Aru; 🇲🇾 Kota Kinabalu, Sabah, Malaysia