Breast CancerRTMNCT02286583
Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast
A study testing Microwave Thermography RTM-01-RES in people with Breast Cancer, run by Labdom Suisse at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Microwave Thermography RTM-01-RES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Menstruating females.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Poliklinik Permai Tanjumg Aru
Kota Kinabalu, Sabah, 88340
Dr. Muzakkar M AN, MD, +6088448100, dralaakarim@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Microwave Thermography RTM-01-RES
- Keywords
- RTM, Female breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Thermography RTM-01-RESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Thermography RTM-01-RES | No intervention | Microwave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues Receives: Device: Microwave Thermography RTM-01-RES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionMay 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labdom Suisse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int], Principal investigator, Labdom Suisse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286583
- Sponsor's protocol ID
- LabdomSuisseRD
- Acronym
- RTM
- Status last verified
- Nov 2014
- First submitted
- 18 Oct 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES
- ClinicalTrials.gov ID
- NCT02286583
- Acronym / sponsor ID
- RTM / LabdomSuisseRD
- Conditions
- Breast Cancer
- Keywords
- RTM, Female breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Labdom SuisseUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Thermography RTM-01-RES | No intervention | Device: Microwave Thermography RTM-01-RESMicrowave thermography with sensitive probe that can detect skin and up to 8 cm microwave radiation deep tissues |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Menstruating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave Thermography RTM-01-RESDivide 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. | Device | Microwave Thermography RTM-01-RES |
Primary outcome
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.
1 secondary outcome
Study the Temperature pattern
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int] principal investigator
Labdom Suisse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Thermography RTM-01-RES in people with Breast Cancer, run by Labdom Suisse at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Alaa Abdelkarim M Fouad, MRCGP Int. (+60128062799, dralaakarim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.