Research and therapeutic innovation: Tissue Resonance InterferoMeter Probe in early detection-screening for rectal cancer.
Alberto Vannelli, Luigi Battaglia and Ermanno Leo.
Fondazione IRCCS “Istituto Nazionale Tumori”, Milan, Italy
Key words: rectal cancer, early detection, population screening, Tissue Resonance InterferoMeter Probe.
1. Introduction
Population screening programs for the early diagnosis of rectal cancer (RC) have the potential to reduce the incidence and mortality from this disease. Most of these programs are based on stool tests or structural exams. Everywhere even though there are different health care systems, financial resources are everywhere limited and the rectal screening with the current knowledge should be applied only on a selected population. Thus, a less expensive, faster, and less invasive RC screening procedure with a similar efficacy would provide a significant advantage for RC prevention in the general population. A recently study for the identification of RC by electromagnetic detection, has identified a method that is rapid, non-invasive, and inexpensive; as compared to the results of endoscopy, electromagnetic detection of rectal cancer was highly specific and highly sensitive (Vannelli et al., 2010).
2. Electro-medical device for non invasive diagnostics
2.1 Historical background
It has been proposed that cancer exposed to a low level of electromagnetic incident waves may behave differently than healthy tissue (Vedruccio et al., 2004). The phenomenon of ‘‘nonlinear resonance interaction,’’ which is produced when the oscillations of an electromagnetic probe are coupled with those from biological tissue, can be used to test for differences between healthy and cancerous tissues.
2.2 Tissue Resonance InterferoMeter Probe
Galileo Avionica, a Finmeccanica Company focused on defence electronics, following a discovery by the physicist Dr. Clarbruno Vedruccio, has applied advanced military technologies to develop a portable electro-medical device for non invasive diagnostics called Tissue Resonance InterferoMeter Probe (TRIMprob), which can detect in real time and at an early stage various disorders from inflammatory conditions to cancers. The device is user friendly and analyses the patient fully dressed and with no discomfort.
2.3 Clinical application
A device containing a nonlinear tuneable oscillator (TRIMprob) has been used with encouraging results in the diagnosis of prostate cancer and breast cancer.
3. TRIMprob and rectal cancer
3.1 Test Principle
The device is made of a thin probe about 30 cm long, powered by batteries and of a receiver. A specific software entirely elaborated by Galileo Avionica acquires, reads and manages the diagnostic data. The TRIMprob emits a beam of coherent electromagnetic waves at very low power which tunes on the specific frequencies of the examined structures. When the electromagnetic field hits a biologically altered tissue, a phenomenon of interference with the analysed structure takes place.
3.2 Test Procedure
The test was performed for each individual patient according to the procedure. The detector was kept in close contact with the pelvic surface and was moved through six planes: A1, posterior right lateral; A2, posterior median; A3, posterior left lateral; B1, anterior right lateral; B2, anterior median; B3, anterior left lateral. The patient stood between the operator and the receiver, at a distance of 120 cm from the receiver. There was a single operator, who was not blinded to the results of the colonoscopy, because the endpoint was the feasibility of this device. The patient was dressed normally, but no metallic objects were allowed on his or her person, and no electronic devices were admitted in the test area.
4. Remarkable experiments
A pilot study has been carried out for the identification of RC by electromagnetic detection, a method that is rapid, non-invasive, and inexpensive (Vannelli et al., 2009). A subsequently study protocol was approved by the Institutional Review Board and Ethics Committee of the Foundation IRCCS Istituto Nazionale Tumori. The ClinicalTtrials.gov ID of the study is: NCT00963794. This study was carried out using a blind and a prospective design, with patients undergoing electromagnetic detection followed by colonoscopy.
5. Phenomenon interpretation
This phenomenon is interpreted by specific algorithms, and allows the detection of cancer and other pathologies: vascular disorders, joint and bone diseases, sinew and muscle injuries, inflammatory conditions, fibromas (Kurzweil et al., 2004). To evaluate the applicability of TRIMprobe electromagnetic signal as a marker for distinguishing between RC and non-RC disease groups, we performed ROC (Receiver Operating Characteristic) curve analysis. ROC curve showed the diagnostic ability of TRIMprobe electromagnetic signal in the differentiation of RC patients versus non-cancer subjects (AUC = 0.96, 95% confidence interval (CI) 0.94 - 0.98; P < 2.2e-16). In our cohort, the sensitivity of the TRIMprobe device for RC was 0.94, specificity was 0.84, negative predictive value was 0.88, positive predictive value was 0.92, and accuracy was 0.90 for the electromagnetic signal cutoff value of 50 U. Indeed, an electromagnetic signal < 50 U was significantly associated with detection of RC by colonoscopy (p < 2.2e-16). Analysis of accuracy by cutoff value indicated that ~50-55 U represent the best cutoff values for detection of RC.
6. Discussion
Since up to 10% of the general population might carry a RC, depending on the age of the population undergoing screening, new easy and non-expensive methods for population screening for RC may be helpful for early detection of such disease (Lance, 2008). The most frequently used screening methods for RC include two general categories: stool tests (tests for occult blood or exfoliated DNA) and structural exams [endoscopy, double-contrast barium enema and computed tomographic colonography (CTC)]. The ageing of the general population in the Western world, with the consequent increase of people at risk of RC, further makes large screening programs based on colonoscopy unfeasible. Still, early detection of RC can save lives and can also decrease the cost of the patient's clinical management, since patients with early neoplastic lesions require simpler surgical resections and treatments than those with advanced disease. Patients with RC diagnosed by colonoscopy and histopathologic analysis showed significantly lower values of the electromagnetic signal as compared to non-RC patients. At a signal threshold of 50 U, defined by our previous study as the optimal threshold in discriminating RC from non-RC patients, the electromagnetic detection showed a highly significant association with the RC status, thus confirming in an independent cohort previous findings.
5 Conclusion
The usefulness of the TRIMprob test as a screening tool needs to be verified in further studies. However, this probe appears promising in the diagnosis of rectal cancer and presents an opportunity for a new screening strategy characterized by simplicity, efficacy, and good patient compliance.
6. Acknowledgments
The authors thank Mrs. Roberta Aceto for her assistance with data collection and MD. Patrizia Gasparini for scientific consulting.
7. Reference
Kurzweil R. and Grossman T. Rodale Books (eds.) (2004). Fantastic Voyage: Live Long Enough to Live Forever, 2004, ISBN 1-57954-954-3.
Lance P. (2008). Colorectal cancer screening: confusion reigns. Cancer Epidemiol Biomarkers Prev, Vol 17, 2008, pp. 2205-7.
Vannelli A., Leo E., Battaglia L. and Poiasina E (2009). Diagnosis of rectal cancer by electromagnetic interactions: preliminary results. Dis Colon Rectum, Vol 52, 2009, pp.162-166.
Vannelli A., Battaglia L., Poiasina E. and Leo E. (2010). Diagnosis of rectal cancer by Tissue Resonance Interaction Method. BMC Gastroenterol, Vol 10, Issue 45, May 2010, pp. 1-6.
Vedruccio C., Meessen A. (2004). EM cancer detection by means of nonlinear resonance interaction. In: Research Symposium, Pisa Italy March 28-31 2004. Extended Paper Book of PIERS2004- Progress in Electromagnetics p 909-12.