The Society of Interventional Oncology (SIO) has today announced the successful early completion of enrolment for the Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) trial. The society states that this milestone was achieved in a record eight months ahead of schedule.
“Reaching our enrolment 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. The ACCLAIM trial is the first society-sponsored study in the field. The primary endpoint of the study estimates the 24-month local tumour progression-free survival of colorectal metastases treated with microwave ablation with a mandatory ablation margin confirmation.
“The early completion of patient enrolment in the ACCLAIM Trial marks a pivotal moment in interventional oncology,” said Constantinos T Sofocleous (Memorial Sloan Kettering Cancer Center, New York, USA), principal investigator of the ACCLAIM trial. “For the first time, we are prospectively validating a reproducible technical endpoint—ablation margin confirmation—in a multicentre 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 collaboration across the medical device industry, with funding provided through grants from Boston Scientific, NeuWave Medical (a subsidiary of Ethicon), 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, SIO president and associate professor of interventional radiology at Attikon University Hospital Athens in Athens, Greece. “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 tumours in 240 patients diagnosed with colorectal cancer liver metastases. Tumours were treated using US Food and Drug Administration (FDA)-cleared and/or CE marked, microwave ablation 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 tumour control.
The study was conducted in collaboration with nine leading cancer centres across the USA and Europe.
