Clinical trial NCT02514837: Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
Official title: Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no applicable; study withdrawn

Brief 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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Sensitivity of the RTM device
timeFrame: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Secondary outcomes:
measure: Predictability of the method
timeFrame: Results obtained from the RTM device will be compared with those obtained by conventional diagnostic techniques at 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: NHS Lothian
name: Michael Dixon, MD
role: PRINCIPAL_INVESTIGATOR
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