Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast (RTM)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Microwave Thermography RTM-01-RES||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02286583
|Contact: Dr. Alaa Abdelkarim M Fouad, MRCGP Int.||+email@example.com|
|Contact: Dr. Mikhail T Tepponefirstname.lastname@example.org|
|Poliklinik Permai Tanjumg Aru||Recruiting|
|Kota Kinabalu, Sabah, Malaysia, 88340|
|Contact: Dr. Muzakkar M AN, MD +6088448100 email@example.com|
|Principal Investigator:||Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int]||Labdom Suisse|