Breast CancerRTMNCT02514837
Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
An observational study of Breast Cancer, run by University of Edinburgh.
Trial summary
A malignant tumor has higher temperature than normal tissue and the temperature of the tumor is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of tumor activity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- RTM
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Feb 2020
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: no applicable; study withdrawn
Who may be able to join
- Patients attending the breast clinic undergoing mammography and/or ultrasound who can give written informed consent.
- The investigators aim to recruit 150 patients likely to have breast cancer clinically and 150 patients who have normal breasts/benign abnormalities.
Who cannot join
- Patients unable to give written informed consent.
- Patients not having appropriate imaging (mammography +/- ultrasound).
About this study
A malignant tumor has higher temperature than normal tissue and the temperature of the tumor is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of tumor activity.
The temperature changes begin in the stage of atypical hyperplasia and increased proliferation and this opens up the possibilities for detection of patients with high risk lesions.
Read more
Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal tissue at the depth of several centimetre and allows visualization of the temperature on the thermogram and temperature field.
It is noninvasive and the measurement of internal temperature is based on receiving natural electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device is absolutely harmless and has no risk because it does not emit any radiation. It can be used repeatedly as a method of monitoring.
Microwave radiometry has successfully completed seven clinical trials of more than 1000 patients in different countries. Microwave device (RTM-01-RES) is used in more than 300 medical centers in 30 countries.
Medical technology of microwave radiometry is included in the nomenclature of medical services in the Russian Federation, the Ministry of Health and is part of the standard of care for patients with malignant tumors of the breast.
This method of microwave radiometry is recommended by leading Russian mammalogists in the National guidelines of breast care.
The investigators would like to use the device in clinics in Scotland and later United Kingdom (UK) for breast diagnosis and monitoring treatment.
During 3 months the investigators aim to examine 150 patients with breast cancer and 150 patients without cancer who will be the control group. The results of temperature measurement will be compared with the results of histology, in particular, tumour cellulants p53 expression and other gene expression data for metabolic biomarkers and other tumor indicator. Statistical analysis of data will be performed. The device and initial training will be provided by RES Company (device producer).
Read the detailed description
The temperature of a malignant tumour is a universal indicator of the growth rate of the tumor.
Tumor temperature can be used as a prediction of the benefit of individual therapies and in monitoring the efficacy of breast cancer treatment.
The temperature of tissue around a malignant tumour is correlated with micro vessel density (MVD) - the main indicator of angiogenesis.
A traditional infrared camera allows measurement of the temperature of the skin and the breast tumor at a depth of several centimetres.
It is well known that it is possible to detect thermal abnormality of internal tissues with the help of measuring the natural electromagnetic radiation in microwave frequency range. Microwave radiometer (RTM-01-RES) allows one to measure noninvasively any temperature changes of internal tissue at the depth of several centimetres and visualize the internal temperature on the thermogram and temperature field.
It was shown that the device can be used for detection of carotid temperature abnormalities and the temperature of the carotid is a good correlation to the risk of stroke in the patient.
Today it is technically possible to obtain non-invasively the information concerning thermal activity of the tumor and use this information for the prediction of individual therapies and monitoring the efficacy of breast cancer treatment.
The clinical trials in Russia show that tumors with a low degree of malignancy have low temperature changes and the tumor with high degree of malignancy have high temperature changes.
Seven clinical trials of (RTM-01-RES) with 1000 patients have shown that 90% of breast malignant tumours have substantial temperature changes (the sensitivity is 85%-95%, specificity 56%-75%).
The standard of care for patients with malignant tumors of the breast is to use microwave radiometry and this is recommended by leading Russian mammalogists in the National guidelines of breast care.
Given that the temperature of a malignant tumor is higher than a benign lesion and that the temperature of more proliferative and thus poorer outlook cancers is greater than less proliferative cancers, the aim is whether with the most up to date technology these temperatures can be measured accurately on the skin.
The benefits of such a device would be
- Diagnostic - to help differentiate benign from malignant lesions.
- Prognostic - to provide insight into the proliferation rate using a non-invasive test.
- Predictive of benefit - to show that changes in temperature predate changes in tumors volume in patients treated with drug therapy initially.
The investigation is non-invasive. If it were possible to demonstrate benefit, then this simple non-invasive test could have a useful role in assessing patients with breast lumps and in particularly breast cancer.
- Conditions
- Breast Cancer
- Being tested
- RTM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTMDevice
Both the internal temperature and skin temperature will be measured non-invasively through the skin using the RTM device
| Study group | Role | What they receive |
|---|---|---|
| Temperature measured by RTM device | Both the internal temperature and skin temperature will be measured non-invasively through the skin. Receives: Device: RTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the RTM device
Measured: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Secondary outcomes (1)
Predictability of the method
Measured: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dixon, MD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514837
- Sponsor's protocol ID
- RTM 2015
- Acronym
- RTM
- Status last verified
- May 2017
- First submitted
- 7 Jul 2015
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gautherie M. Temperature and blood flow patterns in breast cancer during natural evolution and following radiotherapy. Prog Clin Biol Res. 1982;107:21-64. No abstract available.
PubMed 7167480Gautherie M, Gros CM. Breast thermography and cancer risk prediction. Cancer. 1980 Jan 1;45(1):51-6. doi: 10.1002/1097-0142(19800101)45:13.0.co;2-l.
PubMed 7351006Yahara T, Koga T, Yoshida S, Nakagawa S, Deguchi H, Shirouzu K. Relationship between microvessel density and thermographic hot areas in breast cancer. Surg Today. 2003;33(4):243-8. doi: 10.1007/s005950300055.
PubMed 12707816Barrett AH, Myers PC. Subcutaneous temperatures: a method of noninvasive sensing. Science. 1975 Nov 14;190(4215):669-71. doi: 10.1126/science.1188361.
PubMed 1188361Tahir H, Shah E, Siores C, Daskalakis. Non-invasive devices for early detection of breast tissue oncological abnormalities using microwave radio thermometry. HalaGali-Muhtasib. Advances in Cancer Therapy. InTech, 2011; 447-476.
Toutouzas K, Grassos C, Drakopoulou M, Synetos A, Tsiamis E, Aggeli C, Stathogiannis K, Klettas D, Kavantzas N, Agrogiannis G, Patsouris E, Klonaris C, Liasis N, Tousoulis D, Siores E, Stefanadis C. First in vivo application of microwave radiometry in human carotids: a new noninvasive method for detection of local inflammatory activation. J Am Coll Cardiol. 2012 May 1;59(18):1645-53. doi: 10.1016/j.jacc.2012.01.033.
PubMed 22538335Toutouzas K, Synetos A, Nikolaou C, Stathogiannis K, Tsiamis E, Stefanadis C. Microwave radiometry: a new non-invasive method for the detection of vulnerable plaque. Cardiovasc Diagn Ther. 2012 Dec;2(4):290-7. doi: 10.3978/j.issn.2223-3652.2012.10.09.
PubMed 24282729Klemetsen O, Birkelund Y, Jacobsen SK, Maccarini PF, Stauffer PR. DESIGN OF MEDICAL RADIOMETER FRONT-END FOR IMPROVED PERFORMANCE. Prog Electromagn Res B Pier B. 2011;27:289-306. doi: 10.2528/pierb10101204.
PubMed 21779411Bardati F, Iudicello S. Modeling the visibility of breast malignancy by a microwave radiometer. IEEE Trans Biomed Eng. 2008 Jan;55(1):214-21. doi: 10.1109/TBME.2007.899354.
PubMed 18232364Vesnin SG, Kaplan MA, Avakjan RS. Modern microwave radiometry of breast. The tumor of women reproductive systems 2008; 3: 28 -33
Roshkova NI, Smirnova NA, Nazarov AA. Microwave radiometry of breast and the main factors which determine its efficacy. Mammalogy 2007; 3: 21-25
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
- ClinicalTrials.gov ID
- NCT02514837
- Acronym / sponsor ID
- RTM / RTM 2015
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 4 Aug 2015 (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.
A malignant tumor has higher temperature than normal tissue and the temperature of the tumor is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of tumor activity.
The temperature changes begin in the stage of atypical hyperplasia and increased proliferation and this opens up the possibilities for detection of patients with high risk lesions.
Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal tissue at the depth of several centimetre and allows visualization of the temperature on the thermogram and temperature field.
It is noninvasive and the measurement of internal temperature is based on receiving natural electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device is absolutely harmless and has no risk because it does not emit any radiation. It can be used repeatedly as a method of monitoring.
Microwave radiometry has successfully completed seven clinical trials of more than 1000 patients in different countries. Microwave device (RTM-01-RES) is used in more than 300 medical centers in 30 countries.
Medical technology of microwave radiometry is included in the nomenclature of medical services in the Russian Federation, the Ministry of Health and is part of the standard of care for patients with malignant tumors of the breast.
This method of microwave radiometry is recommended by leading Russian mammalogists in the National guidelines of breast care.
The investigators would like to use the device in clinics in Scotland and later United Kingdom (UK) for breast diagnosis and monitoring treatment.
During 3 months the investigators aim to examine 150 patients with breast cancer and 150 patients without cancer who will be the control group. The results of temperature measurement will be compared with the results of histology, in particular, tumour cellulants p53 expression and other gene expression data for metabolic biomarkers and other tumor indicator. Statistical analysis of data will be performed. The device and initial training will be provided by RES Company (device producer).
Detailed description
The temperature of a malignant tumour is a universal indicator of the growth rate of the tumor.
Tumor temperature can be used as a prediction of the benefit of individual therapies and in monitoring the efficacy of breast cancer treatment.
The temperature of tissue around a malignant tumour is correlated with micro vessel density (MVD) - the main indicator of angiogenesis.
A traditional infrared camera allows measurement of the temperature of the skin and the breast tumor at a depth of several centimetres.
It is well known that it is possible to detect thermal abnormality of internal tissues with the help of measuring the natural electromagnetic radiation in microwave frequency range. Microwave radiometer (RTM-01-RES) allows one to measure noninvasively any temperature changes of internal tissue at the depth of several centimetres and visualize the internal temperature on the thermogram and temperature field.
It was shown that the device can be used for detection of carotid temperature abnormalities and the temperature of the carotid is a good correlation to the risk of stroke in the patient.
Today it is technically possible to obtain non-invasively the information concerning thermal activity of the tumor and use this information for the prediction of individual therapies and monitoring the efficacy of breast cancer treatment.
The clinical trials in Russia show that tumors with a low degree of malignancy have low temperature changes and the tumor with high degree of malignancy have high temperature changes.
Seven clinical trials of (RTM-01-RES) with 1000 patients have shown that 90% of breast malignant tumours have substantial temperature changes (the sensitivity is 85%-95%, specificity 56%-75%).
The standard of care for patients with malignant tumors of the breast is to use microwave radiometry and this is recommended by leading Russian mammalogists in the National guidelines of breast care.
Given that the temperature of a malignant tumor is higher than a benign lesion and that the temperature of more proliferative and thus poorer outlook cancers is greater than less proliferative cancers, the aim is whether with the most up to date technology these temperatures can be measured accurately on the skin.
The benefits of such a device would be
- Diagnostic - to help differentiate benign from malignant lesions.
- Prognostic - to provide insight into the proliferation rate using a non-invasive test.
- Predictive of benefit - to show that changes in temperature predate changes in tumors volume in patients treated with drug therapy initially.
The investigation is non-invasive. If it were possible to demonstrate benefit, then this simple non-invasive test could have a useful role in assessing patients with breast lumps and in particularly breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature measured by RTM device | – | Device: RTMBoth the internal temperature and skin temperature will be measured non-invasively through the skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- no applicable; study withdrawn
Key inclusion criteria (2 listed)
- Patients attending the breast clinic undergoing mammography and/or ultrasound who can give written informed consent.
- The investigators aim to recruit 150 patients likely to have breast cancer clinically and 150 patients who have normal breasts/benign abnormalities.
Key exclusion criteria (2 listed)
- Patients unable to give written informed consent.
- Patients not having appropriate imaging (mammography +/- ultrasound).
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 |
|---|---|---|
| RTMBoth the internal temperature and skin temperature will be measured non-invasively through the skin using the RTM device | Device | Temperature measured by RTM device |
Primary outcome
Sensitivity of the RTM device
Time frame: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
1 secondary outcome
Predictability of the method
Time frame: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Background: PubMed 7167480Gautherie M. Temperature and blood flow patterns in breast cancer during natural evolution and following radiotherapy. Prog Clin Biol Res. 1982;107:21-64. No abstract available.
- Background: PubMed 7351006Gautherie M, Gros CM. Breast thermography and cancer risk prediction. Cancer. 1980 Jan 1;45(1):51-6. doi: 10.1002/1097-0142(19800101)45:13.0.co;2-l.
- Background: PubMed 12707816Yahara T, Koga T, Yoshida S, Nakagawa S, Deguchi H, Shirouzu K. Relationship between microvessel density and thermographic hot areas in breast cancer. Surg Today. 2003;33(4):243-8. doi: 10.1007/s005950300055.
- Background: PubMed 1188361Barrett AH, Myers PC. Subcutaneous temperatures: a method of noninvasive sensing. Science. 1975 Nov 14;190(4215):669-71. doi: 10.1126/science.1188361.
- BackgroundTahir H, Shah E, Siores C, Daskalakis. Non-invasive devices for early detection of breast tissue oncological abnormalities using microwave radio thermometry. HalaGali-Muhtasib. Advances in Cancer Therapy. InTech, 2011; 447-476.
- Background: PubMed 22538335Toutouzas K, Grassos C, Drakopoulou M, Synetos A, Tsiamis E, Aggeli C, Stathogiannis K, Klettas D, Kavantzas N, Agrogiannis G, Patsouris E, Klonaris C, Liasis N, Tousoulis D, Siores E, Stefanadis C. First in vivo application of microwave radiometry in human carotids: a new noninvasive method for detection of local inflammatory activation. J Am Coll Cardiol. 2012 May 1;59(18):1645-53. doi: 10.1016/j.jacc.2012.01.033.
- Background: PubMed 24282729Toutouzas K, Synetos A, Nikolaou C, Stathogiannis K, Tsiamis E, Stefanadis C. Microwave radiometry: a new non-invasive method for the detection of vulnerable plaque. Cardiovasc Diagn Ther. 2012 Dec;2(4):290-7. doi: 10.3978/j.issn.2223-3652.2012.10.09.
- Background: PubMed 21779411Klemetsen O, Birkelund Y, Jacobsen SK, Maccarini PF, Stauffer PR. DESIGN OF MEDICAL RADIOMETER FRONT-END FOR IMPROVED PERFORMANCE. Prog Electromagn Res B Pier B. 2011;27:289-306. doi: 10.2528/pierb10101204.
- Background: PubMed 18232364Bardati F, Iudicello S. Modeling the visibility of breast malignancy by a microwave radiometer. IEEE Trans Biomed Eng. 2008 Jan;55(1):214-21. doi: 10.1109/TBME.2007.899354.
- BackgroundVesnin SG, Kaplan MA, Avakjan RS. Modern microwave radiometry of breast. The tumor of women reproductive systems 2008; 3: 28 -33
- BackgroundRoshkova NI, Smirnova NA, Nazarov AA. Microwave radiometry of breast and the main factors which determine its efficacy. Mammalogy 2007; 3: 21-25
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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.
Michael Dixon, MD principal investigator
NHS Lothian
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Edinburgh.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the RTM device (time frame: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514837, which also lists 11 linked publications.
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 19 Aug 2022.