title: Tissue resonance interaction accurately detects colon lesions: A double-blind pilot study.
abstract: OBJECTIVE
  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 χ(2) 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.
  
  
  CONCLUSIONS
  The study confirmed that TRIM provides rapid, accurate, convenient and noninvasive means to identify individuals most likely to benefit from colonoscopy.
authors.affiliation: 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.
authors.forename: Maria P
authors.initials: MP
authors.lastname: Dore
authors.affiliation: 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.
authors.forename: Marcello O
authors.initials: MO
authors.lastname: Tufano
authors.affiliation: 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.
authors.forename: Giovanni M
authors.initials: GM
authors.lastname: Pes
authors.affiliation: 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.
authors.forename: Marianna
authors.initials: M
authors.lastname: Cuccu
authors.affiliation: 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.
authors.forename: Valentina
authors.initials: V
authors.lastname: Farina
authors.affiliation: 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.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Manca
authors.affiliation: 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.
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
mesh_terms: D018256:Adenomatous Polyps / Q000473:pathology*; D000368:Aged; D003106:Colon / Q000473:pathology*; D003110:Colonic Neoplasms / Q000473:pathology*; D003111:Colonic Polyps / Q000473:pathology*; D003113:Colonoscopy; D004311:Double-Blind Method; D004574:Electromagnetic Fields; D004867:Equipment Design; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D006965:Hyperplasia; D007558:Italy; D008280:Magnetics / Q000295:instrumentation*; D059346:Magnets; D008297:Male; D008875:Middle Aged; D009991:Oscillometry / Q000295:instrumentation; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012815:Signal Processing, Computer-Assisted; D014732:Vibration
keywords: Bioscanner; Colon cancer screening; Electromagnetic; Non-invasive diagnosis; Resonance