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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02286583
Recruitment Status : Unknown
Verified November 2014 by Labdom Suisse.
Recruitment status was:  Recruiting
First Posted : November 10, 2014
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Microwave Thermography RTM-01-RES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES
Study Start Date : February 2015
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02286583

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Contact: Dr. Alaa Abdelkarim M Fouad, MRCGP Int. +60128062799
Contact: Dr. Mikhail T Teppone +60138800716

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Poliklinik Permai Tanjumg Aru Recruiting
Kota Kinabalu, Sabah, Malaysia, 88340
Contact: Dr. Muzakkar M AN, MD    +6088448100   
Sponsors and Collaborators
Labdom Suisse
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Principal Investigator: Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int] Labdom Suisse

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Responsible Party: Labdom Suisse Identifier: NCT02286583    
Other Study ID Numbers: LabdomSuisseRD
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: November 2014
Keywords provided by Labdom Suisse:
Female breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases