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The Accuracy of Tissue Resonance Interaction Method Probe (Trimprob Tm) in Non-Invasive Diagnosis of Prostatic Cancer. Analysis of the Results of 782 Patients
Abstract
The aim of our study was to evaluate the real utility of the TRIMprob test before TRUS-guided biopsy approach, putting in relation the number of positive tests of the TRIMprob with the number of positive prostate biopsies that were performed successfully. Sensitivity, Specificity, PPV (Positive predicted value), NPV (Negative predicted value) of the TRIMprob test were analyzed with statistical software package for Social Sciences (SPSS Inc, Chicago, Illinois USA).
... Briefly, the device generates an alternating electromagnetic field that interacts with charged particles (molecules, ions, electrons, and nuclei) in a target tissue leading to a secondary radiation that varies for normal and neoplastic biological tissues [3]. Several pilot clinical studies have shown that TRIM-prob 2 ISRN Urology scanning may be a valuable tool in diagnosing prostate [4][5][6][7][8], breast [9], gastric [10], thyroid [11], rectum [12], and even bladder cancer [13]. ...
... Bellorofonte et al. [4] were the first to evaluate the feasibility and diagnostic accuracy of TRIM-prob scanning in detecting prostate cancer; in their study population of 757 men, the test had a 95.5% sensitivity, a 42.7% specificity, a 63.6% PPV, and an 89.8% NPV. These results have subsequently been replicated by other studies [6][7][8] and even by a multicenter trial [5], thus supporting also the reproducibility of the technique in detecting prostate cancer. ...
... NPV suggests that this test has the potential to replace cystoscopy in evaluating patients at low risk of harboring BC or in those under surveillance after transurethral resection of BC, with significant reductions in healthcare costs, patients' discomfort, and urologists, burden. Such a high NPV, ranging from 84% for prostate cancer to 100% for thyroid and gastric cancer [4][5][6][7][8][9][10][11][12][13], seems to be the common denominator in the studies dealing with electromagnetic detection of cancer and the real strength of this new technology, as it may lead to a reduction of unnecessary invasive tests or biopsies. ...
Objectives. Normal and neoplastic human tissues have different electromagnetic properties. This study aimed to determine the diagnostic accuracy of noninvasive electromagnetic detection of bladder cancer (BC) by the tissue-resonance interaction method (TRIM-prob). Patients and Methods. Consecutive patients were referred for cystoscopy because of (i) microscopic or gross hematuria and/or irritative voiding symptoms and (ii) bladder ultrasounds and urinary cytology findings negative or just suspicious of malignancy. Patients were first submitted to TRIM-prob bladder scanning by a single investigator and then to cystoscopy by another investigator blind to TRIM-prob data. Results. In 125 evaluated patients cystoscopy was positive for BC in 47 and negative in the remaining 78; conversely, TRIM-prob bladder scanning was positive for BC in 53 and negative in 72. In particular, TRIM-prob scanning yielded 7 false positives and only one false negative; therefore, its overall sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were 97.9%, 89.9%, 86.8%, 98.6%, and 93.6%, respectively. Conclusions. TRIM-prob bladder scanning was a simple and quite accurate method for non-invasive electromagnetic detection of BC. If the elevated positive and negative predictive values will be replicated in further well-designed studies, it could be used to screen asymptomatic patients at high risk of BC.
... Using a wave frequency equal to half of the microtubule length was found to optimally detect cancerous growth. Several pilot clinical studies have shown that TRIMprob scanning is a valuable tool in diagnosing cancers developing in prostate [7][8][9][10][11], breast [12], stomach [13], thyroid gland [14], rectum [15], colon [16], or urinary bladder [17,18]. ...
... The receiver of the TRIMprob detects the signal originating from non-linear resonance interactions of intensity expressed in arbitrary units ranging between 0 and 255. TRIMprob is a simple, quick to perform (in this study examina-tion took less than 5 min) test that does not require any prior preparation of the patient, yielding immediate and reproducible results [5,6,11]. Previous clinical studies have shown that TRIMprob scanning is useful in detecting cancers of different localisations. ...
Introduction
Diagnosis of hepatocellular carcinoma (HCC) is considerably delayed, being frequently done in the non-curative stage of disease. The reason for delayed diagnosis is indolent course in early stages and/or unspecific symptoms indistinguishable from underlying cirrhosis. Hitherto methods used for screening of HCC have important limitations. TRIMprob is a non-invasive method, which showed utility in detection of cancers located in prostate, breast, or urinary bladder.
Aim
To determine the diagnostic accuracy of TRIMprob in detecting HCC in cirrhotic liver.
Material and methods
Forty-five patients were prospectively enrolled according to final clinical diagnosis into a group of cirrhosis and HCC or a group of cirrhosis without HCC. A control group consisted of 33 healthy subjects. Hepatocellular carcinoma was diagnosed by computed tomography (CT) or magnetic resonance (MR) and guided biopsy. The TRIMprob examination was performed in each patient. Three wave frequencies were used: 465, 930, and 1395 MHz.
Results
In patients with HCC the intensity of return signal using wave a frequency of 465 MHz was significantly reduced in patients with HCC in comparison to healthy subjects (p < 0.0005), but not to cirrhotic patients without HCC. Moreover, cirrhosis was associated with significantly decreased TRIMprob signal in comparison to healthy liver (p < 0.002). In ROC analysis an optimal cut-off value for detection of HCC was 106 units, which yielded 80% sensitivity.
Conclusions
TRIMprob identifies HCC with good sensitivity; however, the accuracy of this method to identify HCC in screening circumstances may be hindered by attenuation of the resonance interaction signal by cirrhosis itself.
Several reports over the last few decades have shown that the dielectric properties of healthy and malignant tissues of the same body organ usually show different values. However, no intensive dielectric studies of human colon tissue have been performed, despite colon cancer's being one of the most common types of cancer in the world. In order to provide information regarding this matter, a dielectric characterization of healthy and malignant colon tissues is presented. Measurements are performed on ex vivo surgery samples obtained from 20 patients, using an open-ended coaxial probe in the 0.5-18 GHz frequency band. Results show that the dielectric constant of colon cancerous tissue is 8.8% higher than that of healthy tissues (p = 0.002). Besides, conductivity is about 10.6% higher, but in this case measurements do not have statistical significance (p = 0.038). Performing an analysis per patient, the differences in dielectric constant between healthy and malignant tissues appear systematically. Particularized results for specific frequencies (500 MHz, 900 MHz, 2.45 GHz, 5 GHz, 8.5 GHz and 15 GHz) are also reported. The findings have potential application in early-stage cancer detection and diagnosis, and can be useful in developing new tools for hyperthermia treatments as well as creating electromagnetic models of healthy and cancerous tissues.
A new paper by Pokorny, Vedruccio, Cifra, Kucera, titled Cancer physics: Diagnostics based on damped cellular elasto-electrical vibrations in microtubules, recently available on Eur. Biophys. J., discloses the mechanism of active grown cancer tissues interaction with a Non- Linear Resonance Interaction (NLRI) Bioscanner Trimprob diagnostic device that is certified and ready to be used to investigate suspected cases of disease and cancer. This technology spreads early capabilities of cancer detection by means of low level radiofrequency oscillations in UHF band. The system is based on an unique and extremely innovative non- linear radiofrequency oscillator working on 462-465 MHz plus the harmonics. The diseased tissues suspected of cancer, are irradiated by means of a handy probe near field emission, while a spectrum analyzer placed in the far field detects by means of a small antenna, the oscillator interaction within the tissues. The Bioscanner is characterized by a high dynamic range, in the order of 30 or more decibel, and is useful for detection of small cancer agglomerates, if used by a well trained operator. At the resonance, the free running oscillator locks-in on the specific interaction frequency, in a sharp frequency window centered on 462 MHz; the resulting effect is evidenced by a deep decrease of the 462 MHz spectral line propagation in the far field around the oscillator probe. The NLRI provides a selective characterization, like a sort of a electronic biopsy response of biologic tissues in support of modern imaging diagnostics. Further to existing literature describing methods for cancer detections by means of electromagnetic fields this paper shows this innovative in vivo medical diagnostic equipment and some clinical applications.
A new perspective for the use of bioelectromagnetics in biology and in medicine is open. Montagnier and his collaborators highlighted a physical approach to the diagnosis of several diseases, base on detecting the spectra of the DNA of cells, pathogenic agents or tumor cells. The DNA is prepared in an aqueous solution. The method uses the Schuman frequency, or any ELF, to induce the DNA solution to emit electromagnetic signals in the range 300 - 4000 Hz that are producing spectra that result to be typical for each disease. Preliminary tests performed at the facility of Italian CNR – Area Tor Vergata (Rome) – seem to confirm the effectiveness of this diagnostic approach. Further tests have to be performed. The method seems to be related to the same biophysical theory – based on Quantum Electrodynamics – that is the basis of other important effects, now employed to new therapeutic approaches.
Although colonoscopy is effective in screening for colorectal cancer, its high cost and low compliance rates have encouraged a search for different methods. Our study was designed to evaluate the feasibility of rectal cancer detection using a nonlinear tuneable oscillator (TRIMprob), a recently developed device for detecting differences in electromagnetic properties of cancerous and normal tissues.
We tested 228 patients (115 male and 113 female) between March and September 2006: 114 patients with rectal cancer diagnosed on colonoscopy and 114 patients with negative colonoscopy results. The TRIMprob probe was moved over the surface of the pelvic area from the back and the front, with the patient standing, normally dressed, between the operator and the system receiver. The signal variation of three spectral lines, for 465-MHz, 930-MHz, and 1395-MHz frequencies was recorded for each of six probe positions.
Analysis of resonance values showed that only the 465-MHz frequency differentiated patients with rectal cancer from those without cancer at all six probe positions (P < 0.001). With a cutoff value of 50 arbitrary units, the area under the receiver operating characteristic curve was 0.94 (specificity, 85 percent; sensitivity, 94 percent).
The TRIMprob test discriminates well between patients with normal rectal tissue and those with malignant lesions. These preliminary results confirm that electromagnetic detection of rectal cancer is possible and suggest this method of extracorporeal scanning may be useful as a first-level screening tool.
Current methods for bladder cancer investigation involve cystoscopy, ultrasound scanning, and contrast urography, with additional information provided by cytology. These methods, although having a high detection rate, are expensive, time-consuming, invasive, and uncomfortable. Therefore, there is a need for an inexpensive, non invasive, quick, and simple investigation with a high sensitivity and specificity. In this study we evaluate the use of an in vivo electromagnetic (EM) interaction as a non invasive method for detecting cancer. A clinical trial was designed and completed. The main trial target was the feasibility assessment of the novel method by comparing its results with standard cystoscopy. A physical discussion of the EM interaction with bladder cancer tissue is presented. One hundred and fourteen patients referred for cystoscopy by microscopic or gross haematuria, irritative voiding symptoms, or suspected bladder tumor at ultrasound were first submitted to EM scan by means of the TRIMprob system. Cystoscopy was performed on each patient after the TRIMprob examination. Comparison between EM and cystoscopy results provides a high level of agreement (Cohen's K = 0.77, p < 0.001). The TRIMprob performance in malignant cancer cells detection suggests that this in vivo EM waves method is also worth investigating for routine diagnostic procedures.
Follow-up of patients with an initial negative prostate biopsy, but surrounding whom a suspicion of prostate cancer persists, is difficult. In addition, debate exists as to the optimal technique for repeat prostate biopsy.
To assess the cancer detection rate on repeat prostate biopsy.
We reviewed patients who underwent prostate biopsy in our department in 2005 who had >or=1 previous biopsy within the preceding 5 years. Cancer detection rate on repeat biopsy and the influence of the number of biopsy cores were recorded.
Cancer detection rate on repeat biopsy was 15.4%, with approximately 60% detected on the first repeat biopsy, but approximately 10% not confirmed until the fourth repeat biopsy. Gleason score was similar regardless of the time of diagnosis (6.1-6.5). Mean interval between first biopsy and cancer diagnosis (range 18-55 months) depended on the number of repeat procedures. There was an association between the number of biopsy cores and cancer detection.
This study supports the practice of increasing the number of cores taken on initial and first repeat biopsy to maximise prostate cancer detection and reduce the overall number of biopsies needed.
In the evaluation of multinodular goitre, finding a malignant neoplasia is often an unexpected result of the histological diagnosis. TRIMprob (Tissue Resonance Interaction Method Probe) is a portable system for non-invasive diagnosis, that utilises the different electromagnetic properties of healthy and pathological tissues, producing a low-power magnetic field that interacts with the molecular structure of tissues. The interference levels are detected by a receiver device and are elaborated with software in a graph consisting of 3 easily interpretable bands. The objective of our study was to assess the usefulness of the TRIMprob system in the preoperative diagnosis of carcinoma in patients with multinodular goitre. Over the period from January 2005 to March 2006 we used TRIMprob to screen 51 patients with a clinical diagnosis of multinodular goitre, later operated on by total thyroidectomy. We then compared the TRIMprob response with the histological diagnosis on the surgical specimen. The TRIMprob results suggested 46 cases compatible with non-malignant goitre and 5 suspected cancers. The final histological diagnosis confirmed these results with 46 cases of multinodular goitre and 5 papillary carcinomas. The sensitivity, specificity and diagnostic accuracy of the procedure were all 100%. On the basis of these preliminary results, TRIMprob seems to be a highly accurate method for the detection of suspected carcinomas in the context of multinodular goitre. If these results are confirmed, new prospects could be opened up in the diagnosis of thyroid diseases.
To determine, in a multicentre prospective study, the accuracy of the tissue-resonance interaction method (TRIMprob, new technology developed for the noninvasive analysis of electromagnetic anisotropy in biological tissues) in the diagnosis of prostate cancer.
Two hundred patients (mean age 67.4 years) scheduled to have prostatic biopsies (because of a prostate-specific, PSA, antigen level of >/=4 ng/mL or a suspicious digital rectal examination, DRE) were preliminarily examined while unaware of their clinical details using TRIMprob in five different centres. The final diagnosis obtained with TRIMprob was compared with the final histological diagnosis after extended biopsies.
Of the 188 evaluable patients (mean PSA level 9.3 ng/mL, sd 8.8; mean prostate volume 62.0 mL, sd 32.4), 61 (32.4%) had a positive biopsy for adenocarcinoma of the prostate. The overall sensitivity, specificity, positive predictive value, negative predictive value (NPV) and accuracy of TRIMprob were 80%, 51%, 44%, 84% and 60%, respectively. The prostate cancer detection rate after biopsy was significantly higher in patients with a positive examination (49/111, 44%) than in patients with a negative TRIMprob (12/77, 15%; P < 0.001). When TRIMprob results were combined with DRE findings the sensitivity and NPV both increased to 92%.
TRIMprob seems to be a useful tool in the diagnosis of prostate cancer and can increase the accuracy of PSA or DRE results. The high NPV suggests that this new technology might be useful to reduce the indications for prostatic biopsy or repeated series of biopsies in patients suspected of having prostate cancer.
To evaluate the accuracy of the TRIMprob in the diagnosis of prostate neoplasm.
Consecutive patients referred for prostate biopsy were prospectively enrolled. Patients had history taken, physical examination by digital rectal examination (DRE) of the prostate, assessment of total and free serum prostate-specific antigen (PSA) levels, prostate transrectal ultrasonography (TRUS), and TRIMprob test. Indications for prostate biopsy included one or more of the following conditions: total serum PSA levels of 4.0 ng/mL or more, free/total serum PSA ratio of 0.18 or less, positive results on DRE, and suspicious findings on TRUS. Twelve-core, TRUS-guided biopsies were performed with local anesthesia. A blinded investigator performed the TRIMprob test; the lowest value of the signal at 465 MHz was looked for and recorded, although data of the electromagnetic signal at 930 and 1295 MHz were also recorded.
One hundred eleven patients (aged 64.9 +/- 8.1 years, mean +/- standard deviation), enrolled between November 2004 and August 2005, were analyzed. Total serum PSA level was 8.4 +/- 3.6 ng/mL, and free/total serum PSA ratio was 0.15 +/- 0.7. TRIMprob sensitivity for the diagnosis of prostate cancer was 0.86%; specificity and positive and negative predictive values were 0.60 and 0.88; accuracy was 72%. TRIMprob accuracy outperformed any other diagnostic parameter considered, including the rule of chance. The association of TRIMprob and DRE offered a sensitivity and a negative predictive value of 0.86% or greater.
TRIMprob had the highest accuracy rate, among all other tests, for the diagnosis of prostate cancer. Electromagnetic detection with the TRIMprob test seems to be a promising technology and a useful additional tool for the early detection of prostate cancer.
Gastric cancer is currently an important clinical and social problem. TRIMprob is a portable system for the non-invasive diagnosis of gastric cancer, designed to differentiate between normal and pathological tissues on the basis of their electromagnetic characteristics. The aim of our study was to evaluate the accuracy and feasibility of use of the TRIMprob system in diagnosing gastric neoplasms. From January to September 2006 we screened 28 symptomatic patients with TRIMprob; afterwards they underwent an endoscopic and bioptic examination. On the basis of the histological diagnosis these patients were divided into 2 groups: group A (patients with a diagnosis of gastric malignancies) and group B (patients with inflammatory disease). There also was a group C, which was a control group of 15 asymptomatic volunteers. The TRIMprob system located all cases of gastric cancer (group A) with 100% sensitivity, specificity and accuracy. The TRIMprob examination seems to be extremely accurate in diagnosing gastric malignancies. If these results are confirmed, TRIMprob could be used for the early diagnosis of gastric cancer and for selecting symptomatic subjects for gastroscopy.