Computer-aided detection
Unlike other computer-aided detection technologies, GI Genius does not characterize or “diagnose” a lesion, nor does it replace laboratory sampling as a means of confirming a cancer diagnosis.
The technology acts essentially as an extra set of expert “eyes” to detect suspicious lesions during colonoscopy, which should prove helpful, Dr. Johnson and Dr. Glissen Brown both commented.
“When a gastroenterologist looks at the video image, typically, our eyes are focused in the center of that image – that’s where our 20/20 vision is,” Dr. Johnson explained.
The computer has 20/20 vision over the whole image, including the periphery, “so the technology really gives an extremely expanded acuity of vision and highlights areas that we may need to investigate further,” he added.
Dr. Glissen Brown was involved in a trial of another AI device – the real-time automatic polyp detection system (Shanghai Wision AI). That study showed an increase in colonoscopic polyp and adenoma detection rates, but this was mainly because of a higher number of diminutive adenomas detected by the automatic detection system, Dr. Gliseen Brown said. There was no important difference in the number of larger adenomas detected with the device and the number detected without it.
However, there was a significant increase in the detection of hyperplastic polyps when the automatic detection system was used. “We definitely want to look at the false positive rate – both the false positive rate under the camera when we are doing colonoscopy and under the microscope when we do biopsies,” Dr. Glissen Brown acknowledged.
In numerous prospective studies of various computer-aided detection technologies such as the GI Genius system, the false positive rate resulting in the performance of biopsy of insignificant lesions is relatively low, he said.
“Ultimately, the decision to remove or biopsy a lesion is with the physician, because the GI Genius technology just points the provider to the area of concern, and then it’s up to them to look at it and decide whether it needs to be biopsied or not,” Dr. Glissen Brown said.
“So the technology serves more as a digital safety net and points the physician in the right direction, so it shouldn’t lead to much in the way of histologic false positives,” he noted.
The only potential disadvantage to using an AI system such as the GI Genius module is the time it might take for endoscopists to learn how to use it and how much the technology might increase the time required to perform the procedure, he added.
For about 18 months, Dr. Johnson has been running a clinical trial with a similar type of AI technology during colonoscopy. He has found that the learning curve for using these systems is “inordinately short.” Dr. Glissen Brown agreed and suggested that, if physicians are already performing colonoscopies regularly, they could probably learn to use an AI system such as GI Genius in about a week.
In his experience, Dr. Johnson has found that the delay caused by use of an AI system during colonoscopy is “minimal.”
If there is any delay at all, “we know that time in the colon on withdrawal increases the detection of polyps, so more time during withdrawal may be a good thing,” he added. It should be noted that endoscopy societies recommend a withdrawal time of at least 6 minutes, which is one of the metrics used to ensure the quality of a colonoscopy, Dr. Glissen Brown explained.
Indeed, the pivotal study upon which the FDA approved the GI Genius module required a minimum withdrawal time of 6 minutes. Participants said they did not find that using the GI Genius increased withdrawal time, he added.
“I think there is enough prospective evidence at this point to suggest that this technology may really be of benefit to clinicians with a lot of different skill levels, so I would be eager to know how clinicians interact with it in the clinical setting,” Dr. Glissen Brown commented.
Dr. Johnson agreed, noting that “even the good can get better.”
Dr. Johnson disclosed relationships with this news organization, CRH Medical, the American College of Gastroenterology Research Institute, and HyGIeaCare. Dr. Glissen Brown disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Article updated April 21, 2021.