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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Microwave Thermography RTM-01-RES
Sponsored by
Labdom Suisse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring RTM, Female breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Poliklinik Permai Tanjumg AruRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Microwave Thermography RTM-01-RES

Arm Description

Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2014
Last Updated
March 31, 2015
Sponsor
Labdom Suisse
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1. Study Identification

Unique Protocol Identification Number
NCT02286583
Brief Title
Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast
Acronym
RTM
Official Title
Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labdom Suisse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
RTM, Female breast cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microwave Thermography RTM-01-RES
Arm Type
No Intervention
Arm Description
Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues
Intervention Type
Device
Intervention Name(s)
Microwave Thermography RTM-01-RES
Intervention Description
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 Measure Information:
Title
Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)
Description
Ability of the Microwave Thermography RTM-01-RES to detect hotspots in the various breast lesions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Study the Temperature pattern
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
The detected hotspots, to be studdied by the Echo-dobbler to see the ability of early detection of neo-Vascularisation of the malignant tumors.
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Alaa Abdelkarim M Fouad, MRCGP Int.
Phone
+60128062799
Email
dralaakarim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Mikhail T Teppone
Phone
+60138800716
Email
mikhail.teppone@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int]
Organizational Affiliation
Labdom Suisse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinik Permai Tanjumg Aru
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88340
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Muzakkar M AN, MD
Phone
+6088448100
Email
dralaakarim@gmail.com

12. IPD Sharing Statement

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

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