Optical coherence tomography (OCT) developer Perimeter Medical Imaging AI recently provided updates on its ongoing clinical trial assessing the combined use of its B-Series OCT system and ImgAssist AI software during breast conservation surgery.
The company said that based on feedback from the U.S. Food and Drug Administration (FDA), the Perimeter has reached alignment on key elements of the trial. This includes the introduction of an interim analysis, which is expected in the second quarter of 2024.
The following is a summary of the updates:
- Perimeter received FDA clearance to introduce an enhanced AI algorithm in the trial under the existing study protocol. As a result, all clinical trial sites will use the updated AI as patients continue to enroll in the ongoing study.
- Perimeter is permitted to enroll up to 531 participants to acquire statistically significant findings based on the use of the new AI algorithm.
- Perimeter intends to conduct a planned interim analysis in the second quarter of 2024. If statistically significant positive interim results are obtained, the company could end the trial and begin preparing regulatory submissions supporting market clearance. If more data is needed, Perimeter said it may continue with its clinical trial and anticipates study completion by the end of 2024.
- Perimeter said it has received clearance to increase the number of clinical trial sites to support and facilitate patient enrollment. This includes recently adding Mayo Clinic and Baptist MD Anderson in Florida.
- The new enhanced AI leverages additional training data and Perimeter's latest AI advancements. The company expects this updated version of ImgAssist AI to contribute to more accurate classification, as well as fewer false positives and negatives.