Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 7, 2015; 21(25): 7851-7859
Published online Jul 7, 2015. doi: 10.3748/wjg.v21.i25.7851
Tissue resonance interaction accurately detects colon lesions: A double-blind pilot study
Maria P Dore, Marcello O Tufano, Giovanni M Pes, Marianna Cuccu, Valentina Farina, Alessandra Manca, David Y Graham
Maria P Dore, Marcello O Tufano, Giovanni M Pes, Marianna Cuccu, Valentina Farina, Alessandra Manca, Dipartimento di Medicina Clinica e Sperimentale, University of Sassari, 07100 Sassari, Italy
Maria P Dore, David Y Graham, Baylor College of Medicine, Michael E DeBakey VAMC 2002 Holcombe Blvd, Houston, TX 77030, United States
Author contributions: Dore MP, Pes GM and Graham DY designed the study and wrote the manuscript; Dore MP, Tufano MO, Cuccu M, Farina V and Manca A performed the examinations, obtain informed consent and performed personal data collection; Dore MP, Pes GM and Graham DY analyzed the data; all authors have approved the final draft submitted.
Ethics approval: The study protocol was reviewed and approved by the Local Ethics Committee, more specifically by the “Comitato di Bioetica dell’Azienda Sanitaria Locale (A.S.L.) n° 1 di Sassari”.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: None of the authors have conflict of interest that are related to the work submitted for consideration for publication. There are no commercial, personal, intellectual, political or religious interests by any of the authors.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Maria P Dore, MD, PhD, Professor of Gastroenterology, Dipartimento di Medicina Clinica e Sperimentale, University of Sassari, Clinica Medica, Viale San Pietro, n 8, 07100 Sassari, Italy. mpdore@uniss.it
Telephone: +39-79-229886 Fax: +39-79-228207
Received: December 28, 2014
Peer-review started: December 31, 2014
First decision: March 26, 2015
Revised: April 7, 2015
Accepted: May 27, 2015
Article in press: May 27, 2015
Published online: July 7, 2015
Processing time: 192 Days and 10.3 Hours
Abstract

AIM: To investigated the performance of the tissue resonance interaction method (TRIM) for the non-invasive detection of colon lesions.

METHODS: We performed a prospective single-center blinded pilot study of consecutive adults undergoing colonoscopy at the University Hospital in Sassari, Italy. Before patients underwent colonoscopy, they were examined by the TRIMprobe which detects differences in electromagnetic properties between pathological and normal tissues. All patients had completed the polyethylene glycol-containing bowel prep for the colonoscopy procedure before being screened. During the procedure the subjects remained fully dressed. A hand-held probe was moved over the abdomen and variations in electromagnetic signals were recorded for 3 spectral lines (462-465 MHz, 930 MHz, and 1395 MHz). A single investigator, blind to any clinical information, performed the test using the TRIMprob system. Abnormal signals were identified and recorded as malignant or benign (adenoma or hyperplastic polyps). Findings were compared with those from colonoscopy with histologic confirmation. Statistical analysis was performed by χ2 test.

RESULTS: A total of 305 consecutive patients fulfilling the inclusion criteria were enrolled over a period of 12 months. The most frequent indication for colonoscopy was abdominal pain (33%). The TRIMprob was well accepted by all patients; none spontaneously complained about the procedure, and no adverse effects were observed. TRIM proved inaccurate for polyp detection in patients with inflammatory bowel disease (IBD) and they were excluded leaving 281 subjects (mean age 59 ± 13 years; 107 males). The TRIM detected and accurately characterized all 12 adenocarcinomas and 135/137 polyps (98.5%) including 64 adenomatous (100%) found. The method identified cancers and polyps with 98.7% sensitivity, 96.2% specificity, and 97.5% diagnostic accuracy, compared to colonoscopy and histology analyses. The positive predictive value was 96.7% and the negative predictive value 98.4%. Among the 281 non-IBD subjects, there were 7 cases with discordant results (2.5%) between TRIMprob and the reference standard including 5 false positive results (1.8%) and 2 false negative (0.7%) results. The main limitation of the TRIMprob system is the need for trained operators.

CONCLUSION: The study confirmed that TRIM provides rapid, accurate, convenient and noninvasive means to identify individuals most likely to benefit from colonoscopy.

Keywords: Colon cancer screening; Bioscanner; Non-invasive diagnosis; Electromagnetic; Resonance

Core tip: In this study we evaluated the potential role of a non-invasive method: the tissue resonance interaction method or TRIMprob, for enriching the population for colonoscopy with patients most likely to benefit. The apparatus was initially developed by the Italian scientist Clarbruno Vedruccio for military purpose and is another example of technology originally developed for military purpose adapted for medical use. The method is designed to detect differences in electromagnetic properties of pathologic and normal tissues and is currently being used in cancer detection in a number of other organs. The sensitivity, specificity and accuracy of the TRIMprob for detecting and correctly identifying colon cancer or polyps compared to endoscopy with histological examination were greater than 95%.