|
Washington, DC (5 March 2024) – The Society of Interventional Oncology (SIO) proudly announces the European Institute of Oncology, Italy, as the next European site approved for enrollment and activated for the society’s primary clinical trial, “Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure.” Franco Orsi, MD, EBIR, FCIRSE, is the site's Principal Investigator (PI) and Paolo Della Vigna, MD, is the Co-Investigator for the study site, recently approved as the eighth site overall, and third European site, activated in the ACCLAIM Trial.
Constantinos T. Sofocleous, MD, PhD, FSIR, FCIRSE, Memorial Sloan Kettering Cancer Center, is the Global PI for the study. “We are excited and pleased to share the opening of Dr. Orsi’s site,” said Sofocleous. “We look forward to announcing our remaining sites in Europe 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, 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 with 330 tumors treated (approximately 275 subjects) across ten sites in the United States and Europe.
This multi-million-dollar trial is funded collectively through grants from Boston Scientific Corporation, NeuWave Medical, Inc., (part of Ethicon, Inc.), and Varian, a Siemens Healthineers Account.
###
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 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 outcome in its study design, which SIO believes 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.
| 
