title: Clinical application of spectral electromagnetic interaction in breast cancer: diagnostic results of a pilot study.
abstract: OBJECTIVE
  There is a need for a cost-effective method to safely reduce the number of diagnostic procedures women undergo for breast cancer. We tested a new procedure for breast cancer diagnosis based on breast tissue response to low level electromagnetic incident waves.
  
  
  METHODS
  We tested 101 patients with suspicious palpable breast lesions detected by mammography or ultrasonography, who were scheduled to undergo an open biopsy. Using an electromagnetic field generator (tissue resonance interaction method probe [TRIMprob]), we passed the TRIMprob over the breast area and recorded the signal variation of one or more spectral lines (dB1, dB2, dB3). The results were compared with those of a control group as well as with pathology data obtained from excisional biopsy.
  
  
  RESULTS
  No adverse effects of the test were observed. Pathology revealed 86 malignant breast cancers (72 invasive, 14 in situ) and 15 benign conditions. We achieved the best discrimination between normal breasts and lesions using dB1 (dB1 AUC-ROC = 0.8; dB2 AUC-ROC = 0.61; dB3 AUC-ROC = 0.76). With a specificity of 75% to 95%, the sensitivity ranged from 49% to 84%. Tumor or patient variables did not influence the results.
  
  
  CONCLUSIONS
  The TRIMprob test was able to provide some degree of discrimination between normal breast tissue and lesions but not between benign and malignant lesions. The lack of influence of patient age and tumor size on test results might be advantageous in terms of early diagnosis in young women. These preliminary results need to be verified and extended in a preclinical-stage disease setting before clinical applicability can be envisaged.
authors.affiliation: Division of Nuclear Medicine, European Institute of Oncology, Milan, Italy. concetta.de-cicco@ieo.it
authors.forename: Concetta
authors.initials: C
authors.lastname: De Cicco
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
authors.forename: Clarbruno
authors.initials: C
authors.lastname: Vedruccio
authors.forename: Carla
authors.initials: C
authors.lastname: Ricci
authors.forename: Massimo
authors.initials: M
authors.lastname: Balma
authors.forename: Nicole
authors.initials: N
authors.lastname: Rotmensz
authors.forename: Mahila Esmeralda
authors.initials: ME
authors.lastname: Ferrari
authors.forename: Elena
authors.initials: E
authors.lastname: Autino
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Trifirò
authors.forename: Virgilio
authors.initials: V
authors.lastname: Sacchini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paganelli
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D001941:Breast Diseases / Q000175:diagnosis; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D016022:Case-Control Studies; D003937:Diagnosis, Differential; D055590:Electromagnetic Phenomena; D005060:Europe; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008327:Mammography; D008875:Middle Aged; D010865:Pilot Projects; D011237:Predictive Value of Tests; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016217:Ultrasonography, Mammary