by Danielle Bradshaw from In The Cloud Copy
Perspectum Diagnostics says that they will assess their LiverMultiScan to see if it can serve as a means to find patients that may qualify for nonalcoholic steatohepatitis (NASH) clinical testing trials.
The assessment will be a collaborative effort between Mount Sinai, the University of Virginia, the Virginia Commonwealth University, and the Liver Centers of Texas and will center around performing what’s called the Non-Invasive Quantification of Liver Health in NASH (or N-QUAN for short). The N-QUAN will consist of a trial that will involve the participation of 225 people that have suspected NASH.
Andrea Dennis, Ph.D., who is Perspectum’s lead biomarker scientist, talked with Healio Gastroenterology to discuss the project and the future of their research in greater detail.
The interview begins with Healio asking what made Perspectum want to do this study on NASH. Dr. Dennis says that the LiverMultiScan uses MRI technology to provide an image of the condition of patients’ livers. It does this by measuring the fat, iron, and iron corrected T1 (cT1) within the liver.
She goes on to say that because there are a growing number of people with NASH, there needs to be a way to figure out who those people are without the need for invasive methods like biopsies. In order for these potential patients to receive treatments, there needs to be a way to find those who are eligible for any medications that are made available.
Dr. Dennis states that being able to study a patient’s responsiveness to medications for NASH is absolutely necessary to manage both the creation and distribution of these drugs and managing the condition itself. Dennis says that to this end, she and her team input the cT1 biomarker into the LiverMultiScan’s program so that they can see if it’s effective as a viable biomarker. This will then allow them to identify patients who can participate in a NASH clinical trial.
The entire process to be able to even implement the program involved informing the FDA about the merits of the technology for the specified purpose. After the FDA reviewed the evidence of the program’s possible usefulness, they approved and gave the support that allowed Perspectum to continue their research and to provide them with a more detailed plan.
In order to do that, the N-QUAN trial was born. After the testing has been completed, they’ll provide the FDA with the details as a part of their qualification package.
Healio then asks Dennis if she could explain how the study works and what they intend to do with the study results.
Dennis describes the N-QUAN as a cross-sectional study that observes the effectiveness of using the LiverMultiScan vs. a liver biopsy (all participants will be screened with a biopsy as well). It is hoped that locating cT1 with this method will allow for easier identification of those that are at a higher risk for NASH.
The team wishes to gather 225 people from four locations across the US. This will allow for a large enough sample size so that they can perform the scan and will give them a large amount of different data from different groups of people. The team is hoping that this will prove that cT1 is an effective way to find NASH patients.
Healio completes the interview by asking Dennis what they intend to do after the study. From here, she says that they need to gather a large, highly detailed amount of information, and that although they already have a large pool of evidence that validates their theory, they have taken advantage of being able to ask the FDA for a grant to further advance their biomarker qualification program.
Dr. Dennis says that once they’d been awarded the $25,000, they began another complimentary trial on 60 participants that have had a liver biopsy that confirmed their NASH diagnosis to have a LiverMultiScan done. These people will be scanned again in another study called CATE-NASH (characterization and technical evaluation in NASH) after two weeks to show if there are any variances among the group.
The results from this trial will bolster the team’s confidence in cT1 as a biomarker and will become part of the qualification package that they will submit to the FDA.
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