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Colorectal cancer is the third leading cancer-causing death in the United States and is estimated to cause at least 50,000 deaths in 2018. The disease occurs when malignant cells in the colon or rectum grow.
The most common diagnostic tool used by clinicians is colonoscopy, an invasive procedure. An Israeli firm developed a convenient and non-invasive diagnostic tool for the disease, which has been cleared by European regulators with a CE Mark.
This new tool is called the C-Scan, developed by Check-Cap. It is an ingestible pill that is capable of scanning the lower digestive tract including the colon and the rectum. The small device features an autonomous system, an ultra-low dose of x-radiation, and a wireless system to gather information of the target region of the body. The scanning technology of the ingestible pill has two x-ray phenomena to capture 2D and 3D maps of the colon and surrounding tissues.
The first procedure is X-ray fluorescence. The x-radiation photons interact with the contrast material. Before the patient swallows the pill, a contrast agent must be taken orally that mixes with the contents of the colon. The x-ray photons interact with the tissues in the colon mixed with the contrast, making them more visible to the x-ray detectors.
The second procedure is Compton scattering. The photons interact with electrons in the colon wall and the lumen. Some photons scattered in this manner go back in the capsule's direction with an energy tallied to the angle of scattering.
With the combination of these two x-ray phenomena, the readings can determine the distance between the capsule and the colon wall. If the distance between the two increases, the presence of x-ray fluorescence photons increase as well. At the same time, the Compton back-scattered photons decrease that leads to a reduced detection rate. The physical processes of the technology produce a good image quality required for the mapping of the colon area.
"Achieving CE Mark approval is a significant accomplishment and an important milestone for our Company. This is a key validation of C-Scan and its potential as a convenient and comfortable option for identifying polyps in the colon. We look forward to continued progress on our initiatives and remain on target to commence our European post-approval and U.S. pilot trials, each in the 1H2018, as we define marketing and commercialization pathways throughout 2018," said Bill Densel, CEO of Check-Cap.
If compared to the standard screening tests for colorectal cancer, the patient must take troublesome preparations, according to the Mayo Clinic:
- A special diet should be followed the day before the colonoscopy procedure. The special diet consists of drinking clear liquids, such as water, tea, coffee without milk or cream, broth, and carbonated beverages. Beverages with red liquids should be avoided to prevent the color from being confused with blood. No solid food of any kind is allowed in this diet. The doctor may also instruct the patient not to drink anything after midnight before the screening test.
- A special medication called a laxative may be recommended to stimulate bowel movement. Laxatives are commonly prescribed as medications for constipation, but doctors may advise it for patients with scheduled colonoscopy. The mechanism of the medication allows the evacuation of fecal material and debris out of the colon and rectum area.
- Additionally, an enema may be suggested by the physician. It is a fluid to be injected into the rectum as treatment for constipation. If used prior to colonoscopy, enemas will cause large bowel movement to eject fecal material out of the colon and the rectum.
- There are special notes that need to be followed for patients taking other medications. One week before the day of colonoscopy, advise your doctor about your current medications or supplements. Drug effects and pre-existing medical conditions should be discussed with your doctor so medications can be adjusted properly. Examples of medical conditions that must be discussed include diabetes, hypertension, heart problems, and blood clotting issues.
Most of these preparations, such as the special diet and bowel cleaning, are not necessary with the ingestible pill. Also, patients are not required to be sedated before swallowing the pill, unlike with colonoscopy that may cause discomfort or pain. After scanning the colon and rectum area, the pill will be ejected from the rectum and data will be uploaded via USB connection.
The presence of polyps or small clumps of cells the lining of the large intestine is one of the common signs to determine colorectal cancer. While most polyps are small and harmless, some grow exponentially over time that causes colorectal cancer.
[메디컬리포트=Ralph Chen 기자]