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

Breast Cancer Clinical Trial

— RTM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286583
• Other study ID #: LabdomSuisseRD
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2014
• Last updated: March 31, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2014
• Source: Labdom Suisse
• Contact: Dr. Alaa Abdelkarim M Fouad, MRCGP Int.
• Phone: +60128062799
• Email: dralaakarim[@]gmail.com
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public HealthMalaysia: National Medical Research Register
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Malaysia	Poliklinik Permai Tanjumg Aru	Kota Kinabalu	Sabah

Sponsors (1)

Lead Sponsor	Collaborator
Labdom Suisse

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The detected hotspots, to be studdied by the Echo-dobbler to see the ability of early detection of neo-Vascularisation of the malignant tumors.	Half of the sample of the study will be already diagnosed cancer patients, study the neo-vascularisation of the tumor by the Echo-dobbler might give us an idea about how to detect the cancer in earlier stages when it is detected by the RTM	6 months	No
Primary	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	No
Secondary	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	No