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

March 31, 2015 updated by: Labdom Suisse

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88340
        • Recruiting
        • Poliklinik Permai Tanjumg Aru
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: 6 months
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
Time Frame: 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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detected hotspots, to be studdied by the Echo-dobbler to see the ability of early detection of neo-Vascularisation of the malignant tumors.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Labdom Suisse

Investigators

  • Principal Investigator: Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int], Labdom Suisse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 18, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LabdomSuisseRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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