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Washington, DC (13 January 2023) – The Society of Interventional Oncology (SIO) proudly announces Mayo Clinic as the first site approved and activated for enrollment on the society’s primary clinical trial, “Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure.” The Mayo site study physicians include Grant D. Schmit, MD as the Principal Investigator, Matthew R. Callstrom, MD, PhD as Co-Investigator and Anil N. Kurup, MD as Co-Investigator.
The 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. In this multicenter, international trial, SIO proposes to establish microwave ablation (MWA) as the preferred treatment option for selected colorectal liver metastases that can be ablated with sufficient margins. The study will incorporate software to 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 two years post-ablation. This 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.
Dr. Constantinos T. Sofocleous, M.D., Ph.D., FSIR, FCIRSE, Memorial Sloan Kettering Cancer Center, is the Global Principal Investigator for the study. “We are excited and pleased to share the opening of our first site approved to enroll in the ACCLAIM Trial. This study is expected to raise the bar for the standard of care, establishing a reproducible method of achieving long-term sustained local tumor control with microwave ablation,” said Sofocleous. “We look forward to announcing our other sites as they are approved for enrollment to begin.”
Participants of the ACCLAIM Trial will be patients with a diagnosis of colorectal cancer liver metastases. MWA will be performed using an FDA-cleared or CE Marked commercially available MWA system and using margin confirmation (visualization) software. Upon its launch, the ACCLAIM study is expected to have a 3-year enrollment period of approximately 275 participants across sites in the United States and Europe.
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About the Society of Interventional Oncology (SIO)
SIO serves as the only membership-based organization dedicated to the emerging field of interventional oncology (IO), working to establish, nurture, and support IO as the fourth pillar of cancer therapy alongside medical, surgical, and radiation oncology worldwide. IO therapies, such as embolization and tumor ablation, combine the expertise of oncology and radiology and use imaging technology to diagnose and treat localized cancers in ways that are precisely targeted and minimally or non-invasive. For more information, please visit www.sio-central.org.
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