USE OF RTM-01-RES INTEGRAL INTERNAL TEMPERATURE DIAGNOSTIC COMPUTER BASED RADIOMETER FOR BREAST CANCER DIAGNOSIS

Moscow 1999

This Doctor’s Manual covers abilities of the RTM-01-RES integral internal temperature diagnostic computer based radiometer to detect breast cancer and other breast diseases at their earlier stages. The method is based on measuring natural electromagnetic radiation emitted from a patient’s tissues. It allows to detect changes in breast temperature. It detects a temperature differential as well as an absolute temperature. Also Doctor’s Manual covers basics of radiometry, a breast examination method, RTM-features of breast cancer with drafts. Doctor’s Manual is intended for radiologists, oncologists, gynecologists, and surgeons.

Doctor’s Manual is prepared by specialists of the Mammology Branch of the Clinical Radiology Department of the Russian Medicine Academy of Professional Development and the Moscow Mammology Health Center, Dr. Burdina L.M., Dr. Haylenko V.A., Dr. Kizaev E.B., Ph.D. Haylenko V.A., pH. Legkov A.A., Ph.D. Pinhosevich E.G., Ph.D. Mustafin Ch. K., Ph.D. Vaysblat A.V., Ph.D. Vesnin S.G. Tihomirova N.N.

The earlier detection of breast cancer is a major problem for the medical community. In some countries breast cancer is the leading cause of the death for women. In the USA one in every 10 women will experience breast cancer during her lifetime.

Palpation, mammography, or ultrasonography detect anatomical changes in the breast. RTM-Diagnosis detects physiological changes in the examined organ (temperature changes in some areas). RTM-Diagnosis detects internal temperature fields of organs. The temperature changes that may be caused by inflammation or increased cell metabolism, accompanying degeneration of tissues, precede to the anatomical changes that can be detected by palpation, mammography, or ultrasonography. Therefore RTM-Diagnosis has a potential ability to detect cancer at its earlier stage.

The breast cancer lifetime consists of preclinical and clinical phases. At the preclinical stage cancer can not be detected by traditional methods.

The growth rate is represented by a tumor “doubling time” (a time required for doubling mass or number of cells). Despite that the DT varies widely, the tumor growth is always represented by an exponential curve, i.e. the doubling time is a constant for a specific patient.

The specific heat generation is inversely proportional to a DT, therefore the most dangerous tumors with a short DT are “hotter”, and so they are detected by RTM-Diagnosis first of all. Thus RTM-Diagnosis has a unique ability to detect fast growing tumors. Using RTM-Diagnosis in conjunction with other diagnostic methods allows to select patients with fast growing tumors (short DT). According to current data these patients are a quarter of all breast cancer patients.

RTM-Diagnosis can be performed for patients of all ages and with widespread diseases.

Therefore the doctor can perform an examination repeatedly, monitor the disease dynamics as well as effects of radiation and drug therapies.

The method detects natural electromagnetic radiation from the tissues, so it is absolutely harmless for the patients as well as for the medical personnel. Therefore there are no side effects.

Fig. 2.

RTM-Diagnosis must be conducted in the diagnostic room complied with the following requirements:

The RTM-method is based on measuring the internal tissue temperature of investigated organs, in particular, the breast.

For this purpose natural electromagnetic radiation from the internal tissues that is proportional to the temperature of the tissues is measured. Infrared or liquid crystal thermographs measure the skin temperature (epidermis). This temperature relates to the internal temperature marginally.

Comments

A menstrual phase influences on the temperature distribution in the breast. The examination must be performed on the 6-9 day from the beginning of the menstrual period. Menopause women can be examined at any time.

Palpation can influence on the temperature distribution in the breasts, so it must follow RTM-Diagnosis.

The temperature distribution is effected by hormone therapy, drugs, and contraceptives.

The work antenna surface must be wiped with an alcohol tampon before every examination.

The examination technique must not be varied and must comply with the recommendations defined below.

The radiometer may be used in the following modes:

computer based mode;

manual mode (in this case a PC is not used, obtained data are marked in the thermogram manually and if it is necessary they may be input into a computer manually for analysis);

The breast temperature is measured at the centers of the quadrants, at the borders between the quadrants, at nipple points and lymph node points – a total of 20 points. (Fig. 4)

0 – nipple

1 – border between upper quadrants

2 – upper inner quadrant

3 – border between inner quadrants

4 – lower inner quadrant

5 – border between lower quadrants

6 – lower outer quadrant

7 – border between outer quadrants

8 – upper outer quadrant

Fig. 4

To measure the temperature, go through the following steps:

Turn on the radiometer and the PC. Launch the RTM-Diagnosis software. The equipment must be heated for 15 minutes.

While typing the patient’s general data (a surname, a history number, anamnesis), say some words about the method to the patient, point out that it is absolutely harmless for her. Especially it is necessary, if a patient is nervous and is afraid to be diagnosed with cancer.

The patient must lay on the back with her hands behind her head. The breasts are flattened and distribution of the measured points is more convenient for performing the procedure.

For 20-30 seconds contact the antenna work surface with the patient’ skin at the point of the solar plexus projection in order to the antenna be heated to the patient skin temperature and during further measurements the patient not feel cold that can affect a measurement accuracy.

Contact the antenna work surface with the right nipple. Do not press very much, but the entire antenna surface must contact the skin (a visual control).

Substances for improving antenna contact with the skin as they are used in ultrasonography are not required.

The internal temperature sensor must be perpendicular to the surface, as obtained data depend on the antenna slope angle.

Check to make sure that a current measured point displayed on the monitor is the same that you are measuring (right nipple).

In 10-15 minutes, once the temperature gets a stable value, the sound signal and the scheme displayed on the monitor will alert you.

Contact the antenna with the left nipple and repeat the procedure.

The scheme displayed on the monitor prompts a doctor a current measured point. Once you have measured the first point on the right breast, measure the same point on the left breast, and so on.

Once the measurement is complete, review the thermogram. If it is necessary re-measured the temperature at uncertain points.

To check the reliability of the results measure the temperature at the right and left nipple repeatedly. If the results differ from the first data to ± 0.5° C, repeat the whole procedure.

Obtained data can be displayed on the monitor as

Temperature table (Fig. 5a)

Thermogram (Fig. 5b)

Internal temperature field (Fig. 5c)

Risk group scheme (Fig. 5d) showing how much a current patient’s parameters are close to the risk areas created basing on verified breast cancer thermograms.

Numeric estimate how much a current patient is close to the risk group.

Fig. 5a

Fig. 5b

Fig. 5c

Fig. 5d

Fig 5

The data may be printed out. The protocol of RTM-examination is represented in Attachment 1.

Breast cancer is accompanied with the higher temperature due to increased metabolism of tumor cells.

There are the following RTM-features of breast cancer:

Increased thermal differentials between the corresponding sites on the left and right breasts.

Increased differential between sites on the same breast.

Higher dispersion of the temperature differential between the left and right breasts.

Higher standard deviation of differentials between corresponding sites on the left and right breasts.

Differential between the nipple sites on the left and right breast.

Higher nipple temperature in the damaged breast in comparison with the average breast temperature. The age-related changes must be considered.

All verified breast cancer thermograms are stored in a computer. The RTM-features of breast cancer defined above are represented by numeric values. Parameters of all patients with breast cancer are displayed in six 2-D diagrams. Each patient is represented by a point. The mathematical representation of RTM-features is selected so as to points are compact in the diagram. This compact area is called a "risk area". The average breast temperature goes along horizontal axis. Age-related changes in temperature are considered. (Fig. 5d).

If a patient’s thermogram for all RTM-features of breast cancer locates within the "risk area", this patient is similar to the cancer patients and the software, basing on processing results, gives a massage that the patient has breast cancer.

The reliability of these results increases as data are being collected. The results processing that is based on the six criteria makes the diagnostics more reliable.

Consider RTM-features of some cancer types. Ductal cancer is accompanied with a considerable increase in nipple temperature (1-1.5° C) as well as a significant thermal asymmetry at one point. (Fig 6.).

Fig. 6

Fig. 7

The same conditions accompany acute mastitis. However the fact that the method is harmless, if there is any suspicion of this disease, the patient may be treated with drugs and then the RTM-results obtained before and after treatment may be compared. (Fig. 8)

Before treatment

b) After treatment

Fig. 8

RTM-features are more obvious, when fibrous fat involution exists, as transmission loss is less and so a thermal differential increases.

Thin patients have a higher average temperature, so a thermal asymmetry (temperature differential) is less. In these cases the RTM-Diagnostic software may help.

Making conclusion a doctor should consider

Thermogram;

Internal temperature field

Diagnostic expert system conclusion.

Using new diagnostic methods, in particular, radiometric methods in medicine in conjunction with the traditional methods (clinical breast examination, mammography, ultrasonography, needle biopsy) is very useful.

Clinical trials of the device has been conducted at three medical centers of Moscow: the Branch #1 of the Moscow Mammology Health Center, the Municipal Clinical Hospital and the Blohin Oncology Science Center of Russian Science Academy of Medicine. The clinical trials carried out in 900 patients show that the method has a high sensitivity for breast cancer diagnosis (~90%), the method allows to repeat the procedure, monitor the disease dynamics and choose an appropriated treatment. These features are main advantages compared with mammograph-PC. The device has worked at the Mammology Health Center as well as at leading Moscow Oncological Centers. For this period 2000 patients have been examined.

The expert system allows to estimate the conformity of a current patient’s thermogram to various verified pathologic thermogram. The method sensitivity for breast cancer diagnosis is 90%, an accuracy is 84.8%, and a specificity is 78.6%.

The RTM-01-RES internal tissue temperature computer-based radiometer is recommended for using in medicine practice for screening at consulting and oncology rooms and at specialized oncology and mammology centers for detection of breast cancer and the monitoring of treatment.

Attachment 1