Clinical Trial Data
The American BioOptics team has performed both animal and human clinical trials with a primary focus on colon cancer. Published trials to date include a pilot study involving 63 average risk patients undergoing screening colonoscopy at Evanston Northwestern Healthcare, as well as animal trials on rats and mice.
These early results are remarkable, when compared to clinically available FOBT and fecal DNA analyses, which have sensitivities of 10.8% and 18.2%, respectively. Ongoing trials are actively improving upon these initial results.
Both the animal and human clinical trials show the ability of optical technology to predict cancer risk well before the earliest observable changes in the cells’ histology. In addition, results of the human trials showed, for the first time, the ability of ABO’s optical technology to predict risk of advanced polyps throughout the colon in both experimental colorectal cancer models and humans.
Selected Clinical Papers
- Rectal Optical Markers for In-vivo Risk Stratification of Premalignant Colorectal Lesions
by Radosevich AJ, Mutyal NN, Eshein A, Gould B, Nguyen TQ, Rogers JD, Goldberg MJ, Bianchi LK, Konda V, Rex DK, Yen EF, Backman V, and Roy HK.
Clin Cancer Res October 1, 2015 21; 4347.
- In Vivo Risk Analysis of Pancreatic Cancer Through Optical Characterization of Duodenal Mucosa
by N.N. Mutyal, A.J. Radosevich, S. Bajaj, V. Konda, U.D. Siddiqui, I. Waxman, M.J. Goldberg, J.D. Rogers, B. Gould, A. Eshein, S. Upadhye, A. Koons, M. Gonzalez, H.K. Roy, V. Backman.
Pancreas, 44(5), 735-741 (2015). PMC4464933.
- Buccal spectral markers for lung cancer risk stratification
by A.J. Radosevich, N.N. Mutyal, J.D. Rogers, B. Gould, T.A. Hensing, D. Ray, V. Backman, H.K.Roy,.
PLoS One, 9(10): e110157 (2014).
- “Inducible Nitric Oxide Synthase (iNOS) Mediates the Early Increase of Blood Supply (EIBS) in a Pre-dysplastic Stage of Colon Carcinogenesis”
by H. K. Roy, R. K. Wali, Y. Kim, Y. Liu, J. Hart, D. P. Kunte, J. L. Koetsier, M. J. Goldberg, V. Backman.
FEBS, 581 (20), 3857-3862 (2007).
- OpticalMarkers in DuodenalMucosa Predict the Presence of Pancreatic Cancer, Clinical Cancer Research, 13(15), 4392-4399 (2007) (feature article).
by Y. Liu, R. E. Brand, V. Turzhitsky, Y. L. Kim, H. K. Roy, N. Hasabou, C. Sturgis, D. Shah, C. Hall, V. Backman.
National Science Foundation Press Release
- Risk-Stratification of Colon Carcinogenesis through Enhanced Backscattering (EBS) Spectroscopy Analysis of the Uninvolved Colonic Mucosa
by H. K. Roy, Y. L. Kim, Y. Liu, R. K. Wali, M. J. Goldberg, V. Turhitsky, J. Horwitz, V. Backman.
Clinical Cancer Research, 19(3), 961-968 (2006).
- Spectral Markers in Preneoplastic Intestinal Mucosa: An Accurate Predictor of Tumor Risk in the MIN Mouse
by H. K. Roy, Y. Kim, R. K. Wali, Y. Liu, J. Koetsier, A. Kromine, D. P. Kunte, M. J. Goldberg, V. Backman.
Cancer Epidemiology, Biomarkers & Prevention, 14(7), 1639-1645 (2005).
- Increased Microvascular Blood Content is an Early Event in Colon Carcinogenesis
by R. K. Wali, H. K. Roy, Y. L. Kim, Y. Liu, J. L. Koetsier, D. P. Kunte, M. J. Goldberg, V. Turzhitsky, V. Backman.
Gut, 54, 654-660 (2005).
- Four-Dimensional Elastic Light-Scattering Fingerprints as Preneoplastic Markers in the Rat Model of Colon Carcinogenesis
by H. K. Roy, Y. Liu, R. Wali, Y. L. Kim, A. K. Kromine, M. J. Goldberg, and V. Backman.
Gastroenterology, 126,1071-1081 (2004).