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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02286583
Acronym
RTM
Enrollment
2000
Registered
2014-11-10
Start date
2015-02-28
Completion date
2015-10-31
Last updated
2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

RTM, Female breast cancer

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.

Interventions

DEVICEMicrowave 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.

Sponsors

Labdom Suisse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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.

Design outcomes

Primary

MeasureTime frameDescription
Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)6 monthsAbility of the Microwave Thermography RTM-01-RES to detect hotspots in the various breast lesions.

Secondary

MeasureTime frameDescription
Study the Temperature pattern3 monthsThe 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

MeasureTime frameDescription
The detected hotspots, to be studdied by the Echo-dobbler to see the ability of early detection of neo-Vascularisation of the malignant tumors.6 monthsHalf 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

Countries

Malaysia

Contacts

Primary ContactDr. Alaa Abdelkarim M Fouad, MRCGP Int.
dralaakarim@gmail.com+60128062799
Backup ContactDr. Mikhail T Teppone
mikhail.teppone@gmail.com+60138800716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026