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Approved by V.M. Kluzev Head of the Burdenko Major Clinical HospitalMajor-General of medical military service

 

Clinical trial protocol of RTM-01-RES

(Moscow)

Basis: Permission of # 161/7/2/6245 of 26.11.98

In the Radiological Centre of the Burdenko Major Military Hospital from 17 October to 21 December 2000 the clinical trail of the RTM‑01‑RES was conducted.

The purpose of the trial was to evaluate the possibility to use the RTM‑01‑RES diagnostic system to detect breast cancer and select risk patients in the military hospitals. During the trial 51 women were examined.

All patients underwent independent CBE, ultrasound, mammography and RTM‑Diagnosis. Final diagnoses were based on the pathologoanatomic investigation. The patients can be divided into the following disease groups:

Table 1

Disease

Number of Patients

Coincidence of Diagnoses

RTM‑Diagnosis

Breast cancer

16

13

3 - risk group

Fibroadenoma

6

4

2 - thermogram has features of breast cancer

Proliferative Fibroadenoma

1

1

-

Mastopathy

26

23

3 risk group

Cyst

2

1

1 the thermogram has features of breast cancer

Total:

51

   

It should be noted that RTM‑Diagnosis missed no cancer.

Conclusion: RTM‑01‑RES is recommended to be used for screening, diagnosis of breast diseases and monitoring the treatment in hospitals and health centres of the Ministry of Defence.

Signed by

K.A.Teterin

Chief radiologist and Head of the Radiological Centre of the Burdenko Major Clinical Hospital

This is a translation copy. The original is in Russian.

 

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