NCT02514837

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
4.1 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 19, 2022

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

July 7, 2015

Last Update Submit

August 17, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of the RTM device

    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

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

Study Arms (1)

Temperature measured by RTM device

Both the internal temperature and skin temperature will be measured non-invasively through the skin.

Device: RTM

Interventions

RTMDEVICE

Both the internal temperature and skin temperature will be measured non-invasively through the skin using the RTM device

Temperature measured by RTM device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

no applicable; study withdrawn

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 7167480BACKGROUND

  • Gautherie 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.

    PMID: 7351006BACKGROUND

  • Yahara 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.

    PMID: 12707816BACKGROUND

  • Barrett AH, Myers PC. Subcutaneous temperatures: a method of noninvasive sensing. Science. 1975 Nov 14;190(4215):669-71. doi: 10.1126/science.1188361.

    PMID: 1188361BACKGROUND

  • Tahir 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

  • 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.

    PMID: 22538335BACKGROUND

  • Toutouzas 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.

    PMID: 24282729BACKGROUND

  • Klemetsen 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.

    PMID: 21779411BACKGROUND

  • Bardati 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.

    PMID: 18232364BACKGROUND

  • Vesnin SG, Kaplan MA, Avakjan RS. Modern microwave radiometry of breast. The tumor of women reproductive systems 2008; 3: 28 -33

    BACKGROUND

  • Roshkova NI, Smirnova NA, Nazarov AA. Microwave radiometry of breast and the main factors which determine its efficacy. Mammalogy 2007; 3: 21-25

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Dixon, MD

    NHS Lothian

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

August 4, 2015

Study Start

September 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

August 19, 2022

Record last verified: 2017-05