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Washington, DC, USA (28 July 2025) – The Society of Interventional Oncology (SIO) proudly announces the successful early completion of enrollment for the Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) Trial. This milestone was achieved a record-setting eight months ahead of schedule.
“Reaching our enrollment target eight months ahead of schedule reflects the strategic coordination and commitment driving the ACCLAIM Trial — from our dedicated staff to our principal investigators,” said Jena Eberly Stack, SIO Executive Director. “From site activation to patient recruitment, this recent milestone showcases what’s possible when clinical excellence is matched with a shared commitment to advancing cancer care.”
The ACCLAIM Trial is the first global, prospective study to incorporate an objective and reproducible technical endpoint into its design, setting a new standard for clinical research in interventional oncology. The ACCLAIM Trial is the first society-sponsored study in the field. The primary endpoint of the study estimates the 24-month local tumor progression-free survival of colorectal metastases treated with MWA with a mandatory ablation margin confirmation.
“The early completion of patient enrollment in the ACCLAIM Trial marks a pivotal moment in interventional oncology,” said Constantinos T. Sofocleous, MD, PhD, FSIR, FCIRSE, Professor of Radiology at Weill-Cornell Medical College, Principal Investigator of the ACCLAIM Trial and interventional oncologist/radiologist at Memorial Sloan Kettering Cancer Center. “For the first time, we are prospectively validating a reproducible technical endpoint — ablation margin confirmation — in a multicenter trial, that not only redefines procedural success but more importantly, improves outcomes for patients with colorectal liver metastases.”
This multi-million-dollar study also represents a pioneering collaboration across the medical device industry, with funding provided through grants from Boston Scientific Corporation, NeuWave Medical, Inc. (a subsidiary of Ethicon, Inc.), and Varian, a Siemens Healthineers company.
“As the first society-sponsored study in the field, ACCLAIM sets a new precedent for clinical research,” said Alexis Kelekis, MD, PhD, EBIR, FCIRSE, FSIR, SIO President and associate professor of interventional radiology at Attikon University Hospital Athens. “Its success reflects the power of collaboration between leading institutions and industry partners, and it paves the way for more precise, evidence-based approaches to cancer treatment.”
The ACCLAIM Trial enrolled 330 tumors in 240 patients diagnosed with colorectal cancer liver metastases in 29 months. Tumors were treated using FDA-cleared and/or CE marked, microwave ablation (MWA) systems and advanced margin confirmation software. The study’s primary endpoint is local disease progression at two years post-ablation, aiming to determine whether complete margin coverage during ablation correlates with long term tumor control.
The study was conducted in collaboration with nine leading cancer centers across the United States and Europe. The participating institutions and their respective site investigators are as follows:
- Amsterdam UMC – Cancer Center, Netherlands
- Martijn R. Meijerink, MD, PhD, FCIRSE
- Baptist Health Miami Cancer Institute
- Govindarajan Narayanan, MD
- European Institute of Oncology, Italy
- Franco Orsi, MD, EBIR, FCIRSE
- Lausanne University Hospital and University of Lausanne, Switzerland
- Rafael Duran, MD
- Mayo Clinic Rochester
- Matthew R. Callstrom, MD, PhD
- Anil N. Kurup, MD
- Grant D. Schmidt, MD
- MD Anderson Cancer Center
- Bruno Odisio, MD, FSIR
- Medical College of Wisconsin
- William Rilling, MD, FSIR
- Memorial Sloan Kettering Cancer Center
- Constantinos T. Sofocleous, MD, PhD, FSIR, FCIRSE
- Sotirchos Vlasios, MD
- National and Kapodistrian University of Athens, Greece
- Dimitrios Filippiadis, MD, PhD, MSc, EBIR
For more information, please visit, www.sio-central.org/ACCLAIM-Trial.
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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.
About the ACCLAIM (Ablation with Confirmation of Colorectal Liver Metastases) Trial
In this prospective, single arm, multi-center, 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 is the first global, prospective trial to use an objective and reproducible technical endpoint in its study design. SIO believes that the results of the ACCLAIM trial will drive important changes to future treatment guidelines. 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. For more information, please visit, www.sio-central.org/ACCLAIM-Trial.
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