Newswise – San Francisco, CA (September 24, 2024) – In a multisite, prospective, randomized controlled trial published in JAMA Network Open, 3D digital images generated by Ceevra, Inc. were shown to result in trifecta outcomes rates for prostate cancer patients that were nearly five times the rates achieved with multiparametric prostate MRI (mpMRI) only. A trifecta outcome was defined as one in which the patient, after 18-24 months, had undetectable PSA without having undergone radiation or androgen deprivation therapy, a SHIM score that was categorically the same or greater than preoperatively, and complete urinary continence.
Ceevra is an advanced surgical visualization company that uses machine learning to generate patient-specific 3D digital models from standard CT scans and MRIs. Ceevra’s 3D images are used by leading surgeons in multiple specialties for preoperative planning, patient counseling and intraoperative visualization. Ceevra’s 3D images are generated entirely by Ceevra, requiring no effort from Ceevra’s customers beyond uploading the source CT and MR imaging to Ceevra’s cloud.
In the trial, led by researchers at UCLA, UC Irvine, Swedish Medical Center, Mount Sinai, UNC Chapel Hill and Mayo Clinic, patients undergoing a robotic prostatectomy were randomized to a control arm, in which the surgeon used only the patient’s mpMRI during preoperative planning, and an intervention arm, in which the surgeon additionally used a Ceevra 3D model. Key endpoints measured 18-24 months after the procedures had the following results:
|
Endpoint |
Control Arm |
Intervention Arm |
|
Detectable PSA |
18% |
0% |
|
Rates of adjuvant therapy |
32% |
3% |
|
Urinary continence |
0.31 |
0.36 |
|
Erectile function |
9.8 |
16.8 |
|
Rates of trifecta outcomes |
10% |
48% |
“This first-of-kind randomized trial demonstrates the significant patient outcomes benefits of using Ceevra 3D models for planning and performing prostatectomy procedures,” said Russ Yoshinaka, Ceevra’s chief executive officer. “As compared to standard mpMRIs, Ceevra’s 3D models provide surgeons with a far better understanding of the tumor location, potential extracapsular extension, and proximity to the neurovascular bundles. The results of the trial demonstrate that this improved visualization dramatically improves the surgeon’s ability to achieve the best possible results for the patient regarding cancer control and functional outcomes.”
About Ceevra, Inc.
Ceevra is an advanced surgical visualization company using machine learning to transform CTs & MRIs into patient-specific 3D digital models. Ceevra’s 3D models have been used in over 3,000 operations by some of the world’s best surgeons to save organs, discharge patients earlier, and reduce risk of cancer recurrence. Ceevra is FDA cleared and CE Marked for all types of surgeries, and in 2023 became the first company cleared by the FDA to use machine learning technology in generating 3D images for urologic and thoracic surgical planning. For more information, visit www.ceevra.com.
