Publications

An x-ray based capsule for colorectal cancer screening incorporating single photon counting technology

Ronen Lifshitz; Yoav Kimchy; Nir Gelbard; Avi Leibushor; Oleg Golan, et al. (2017)
An x-ray based capsule for colorectal cancer screening incorporating single photon counting technology. Proc. SPIE 10132, Medical Imaging 2017: Physics of Medical Imaging, 101321O (March 9, 2017); doi:10.1117/12.2254242

An ingestible capsule for colorectal cancer screening, based on ionizing-radiation imaging, has been developed and is in advanced stages of system stabilization and clinical evaluation. The imaging principle allows future patients using this technology to avoid bowel cleansing, and to continue the normal life routine during procedure. The Check-Cap capsule, or C-Scan ® Cap, imaging principle is essentially based on reconstructing scattered radiation, while both radiation source and radiation detectors reside within the capsule. The radiation source is a custom-made radioisotope encased in a small canister, collimated into rotating beams. While traveling along the human colon, irradiation occurs from within the capsule towards the colon wall. Scattering of radiation occurs both inside and outside the colon segment; some of this radiation is scattered back and detected by sensors onboard the capsule.

http://dx.doi.org/10.1117/12.2254242


Phantom system for intraluminal x-ray imaging of the human colon

Ronen Lifshitz ; Sivan Nawi-Srur ; Batia Katz ; Lena Milman ; Dmitry Gubich, et al. (2017)
Phantom system for intraluminal x-ray imaging of the human colon. Proc. SPIE 10132, Medical Imaging 2017: Physics of Medical Imaging, 101325A (March 9, 2017); doi:10.1117/12.2254252

The Check-Cap capsule, C-Scan® Cap, performs intraluminal imaging of the human colon based on X-Ray scatter processes. Basic performance of such a system can be demonstrated using various tube-like phantom objects. Also, from a perspective of capsule dynamics, actuators can and have been used for capsule manipulation. Nevertheless the actual situation of a capsule in use is extremely complex, both in terms of the imaging-target object itself and the capsule dynamics within the same. In order to allow study of imaging system performance in a pseudo-clinical environment, a specialized phantom system has been developed. A tissue-equivalent material has been developed in-house, so as to allow simple usage and flexibility for making a wide variety of phantoms, simple tubes as well as extremely complex segments of the human colon which can possibly demonstrate adenomas.

http://dx.doi.org/10.1117/12.2254252


Reconstruction method for x-ray imaging capsule

Daniel Rubin ; Ronen Lifshitz ; Omer Bar-Ilan ; Noam Weiss ; Yoel Shapiro, et al. (2017)

Reconstruction method for x-ray imaging capsule. Proc. SPIE 10132, Medical Imaging 2017: Physics of Medical Imaging, 101324S (March 9, 2017); doi:10.1117/12.2255051
A colon imaging capsule has been developed by Check-Cap Ltd (C-Scan® Cap). For the procedure, the patient swallows a small amount of standard iodinated contrast agent. To create images, three rotating X-ray beams are emitted towards the colon wall. Part of the X-ray photons are backscattered from the contrast medium and the colon. These photons are collected by an omnidirectional array of energy discriminating photon counting detectors (CdTe/CZT) within the capsule. X-ray fluorescence (XRF) and Compton backscattering photons pertain different energies and are counted separately by the detection electronics. The current work examines a new statistical approach for the algorithm that reconstructs the lining of the colon wall from the X-ray detector readings.

http://dx.doi.org/10.1117/12.2255051


Radiographic capsule-based system for non-cathartic colorectal cancer screening

Kimchy Y, et al. (2017) Radiographic capsule-based system for non-cathartic colorectal cancer screening. Abdom Radiol. DOI: 10.1007/s00261-016-1026-y 65:371–373

Many patients are reluctant to undergo optical colonoscopy for colorectal cancer screening. The Check-Cap colon imaging system is a non-invasive test that comprises an ingestible imaging capsule that emits and detects ultralow- dose radiation. The capsule generates a 3D reconstruction of the colonic lumen for detection of polyps and cancer. Preliminary preclinical and clinical testing has demonstrated safety and feasibility. Mean radiation dose is estimated at 0.04 mSv. In conclusion, we describe a novel capsule-based, patient-friendly colorectal test that holds potential for non-invasive screening.


A novel prepless X-ray imaging capsule for colon cancer screening

Gluck N, Shpak B, Brun R, et al. (2016) A novel prepless X-ray imaging capsule for colon cancer screening. Gut. 65:371–373

The demand for bowel cleansing hampers participation in screening colonoscopy, while poor preparation impairs adenoma detection. A novel prepless X-ray imaging capsule for colon screening is presented; the capsule emits low dose X-rays, which are scattered by ingested contrast agent mixed with colon contents, and sensed by detectors in the capsule to generate high-resolution three-dimensional (3D) imagery of the colon without bowel cleansing. Following preliminary studies with implanted polyps in synthetic colon phantoms, bovine cadaver and live swine, and human experiments with dummy capsules (n=75), 49 patients swallowed the capsule with natural excretion in 48 after 73.2±45.4 h. Pedunculated and sessile polyps were clearly seen and validated by subsequent colonoscopy. Total radiation exposure was ultra-low (0.03±0.007 mSv).


A novel prepless X-ray imaging capsule for colon cancer screening: Correlation between capsule and colonoscopic findings

Gluck N, et al. A novel prepless X-ray imaging capsule for colon cancer screening: Correlation between capsule and colonoscopic findings. Presented at the UEGW Meeting, 2016.

Safety evaluation of a novel, preparation-free, X-ray imaging capsule and correlation of clinical findings to colonoscopy has been performed. Quantitative ultra-low dose X-ray imaging and detection of polyps of different sizes and polyp types was achieved in non-prepped colons of human subjects.
Further efficacy validation of this X-ray based CRC screening technology will be performed in multicenter studies.


Potential screening benefit of a colorectal imaging capsule that does not require bowel preparation

Chatrath H, Rex DK. Potential screening benefit of a colorectal imaging capsule that does not require bowel preparation. J Clin Gastroenterol. 2014: 48(1): 52-54.

Introduction: Check-Cap is a capsule device that images the colon using low-dose radiation (total dose equivalent to a plain abdominal radiograph) and does not require bowel preparation. Check-Cap is in development for colorectal cancer imaging.
Aim: To survey patients in a primary care setting for their preferences for Check-Cap versus fecal occult blood testing (FOBT), including among patients who decline colonoscopy.
Methods: Patients aged 50 and older presenting to the general medicine and family practice clinics of Indiana University Health sites within a 3-month period were approached during clinic visits. A total of 502 patients who agreed to participate were given the opportunity to complete an anonymous survey (Supplementary Appendix 1, http://links.lww.com/JCG/A71) regarding their preferences for colon cancer screening. The survey presented procedure descriptions and projected accuracies for colonoscopy, FOBT, and Check-Cap. For Check-Cap, projected sensitivity was 80% for cancer and 50% for large polyps.
Results: The mean age of the subjects was 61.6 years, 39% were males, 44% white, 62% of patients had prior colonoscopy, and 26% had prior polypectomy. We defined 3 groups of patients—those that had never had a colonoscopy (NC)—38%, those who had a colonoscopy but no polypectomy (CNP)—36%, and those who had a colonoscopy and polypectomy (CP)—26%. Overall, 284 patients (57%) were willing to undergo a future colonoscopy. Patients with prior colonoscopy and polypectomy were more willing to get another colonoscopy than the other 2 groups (CP: CNP: NC=78%:64%:38%; P<0.0001). Willingness to undergo colonoscopy decreased with age in all the 3 groups.
Among those not willing to undergo colonoscopy, 30% were willing to undergo Check-Cap, 20% were willing for FOBT), 25% were willing to do both, and 24% were not willing for either test. Among those who declined future colonoscopy, 40% reported Check-Cap as their preferred screening test versus 22% for FOBT; P=0.0002.
Conclusion: Our survey suggests that an imaging capsule like Check-Cap could contribute to screening adherence among patients who decline colonoscopy, provided that it can achieve projected sensitivities of 80% for cancer and 50% for large polyps.