Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer (RTM)

August 17, 2022 updated by: University of Edinburgh

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

  1. Diagnostic - to help differentiate benign from malignant lesions.
  2. Prognostic - to provide insight into the proliferation rate using a non-invasive test.
  3. 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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

no applicable; study withdrawn

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients unable to give written informed consent.
  • Patients not having appropriate imaging (mammography +/- ultrasound).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Temperature measured by RTM device
Both the internal temperature and skin temperature will be measured non-invasively through the skin.
Device: RTM
Both the internal temperature and skin temperature will be measured non-invasively through the skin using the RTM device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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 obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Principal Investigator: Michael Dixon, MD, NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTM 2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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