SIO Begins ACCLAIM Trial of Ablation to Treat Colorectal Liver Metastases

March 3, 2023—The Society of Interventional Oncology (SIO) announced the commencement of its primary clinical trial, ACCLAIM—Ablation With Confirmation of Colorectal Liver Metastases. The multicenter, international, prospective trial will evaluate microwave ablation (MWA) to treat colorectal liver metastases.

SIO stated that it proposes to establish MWA as the preferred treatment option for selected colorectal liver metastases that can be ablated with sufficient margins.

The ACCLAIM trial will enroll patients with a diagnosis of colorectal cancer liver metastases. MWA will be performed using an FDA-cleared or CE Mark-approved commercially available MWA system and using margin confirmation (visualization) software. The software will assess the ablation zone and margins and determine if achieving complete margins during an ablation equates to procedural success, where the primary outcome is local disease progression at 2 years postablation.

The ACCLAIM study is expected to enroll 275 patients at sites in the United States and Europe during a 3-year enrollment period.

The first patient in the study has been enrolled and treated at The University of Texas MD Anderson Cancer Center in Houston, Texas. Bruno C. Odisio, MD, is the Principal Investigator for the recently approved and activated study site.

The global Principal Investigator for the ACCLAIM trial is Constantinos T. Sofocleous, MD, with Memorial Sloan Kettering Cancer Center in New York, New York.

“We are excited and pleased to share the first patient has been enrolled and treated in the ACCLAIM trial,” commented Dr. Sofocleous in the SIO press release. “This is a significant milestone for this important project. We look forward to announcing our other sites in the United States and Europe as they are approved for enrollment to begin.”

According to SIO, the ACCLAIM study is the first global, prospective trial to use an objective and reproducible technical outcome in its study design, which SIO believes will drive important changes to future treatment guidelines.

The multimillion-dollar trial is funded collectively through grants from Boston Scientific Corporation, NeuWave Medical, Inc. (part of Ethicon, Inc.), and Varian, a Siemens Healthineers company.

More information can be found at SIO's ACCLAIM trial website here.