March 22, 2023 – As part of an international clinical trial, Miami Cancer Institute and Miami Neuroscience Institute, part of Baptist Health South Florida, have conducted the first low-intensity focused ultrasound (LIFU) aided liquid biopsy in the state of Florida in a patient with glioblastoma, most aggressive form of brain cancer. Biopsies in patients with brain cancers are challenging as they often require invasive procedures and the blood-brain barrier mostly prevents the leaking of tumor DNA into the bloodstream, therefore making detection of cancer in the patient’s blood less sensitive. This ongoing study aims to show that LIFU is a viable way of increasing circulating tumor DNA (ctDNA) in the blood, allowing for non-invasive detection of glioblastoma.
“This is an incredibly exciting and important study that has the potential to alter how we follow tumors in patients with brain tumors,” said Manmeet S. Ahluwalia, M.D., MBA, FASCO deputydirector, Fernandez Family Foundation Endowed Chair in Cancer Research, chief of medical oncology, and chief scientific officer of Miami Cancer Institute, as well as national principal investigator of the study. “Unlike other types of malignant lesions, brain cancers are more difficult to detect in the blood because of a protective lining in the brain – the blood-brain barrier – that prevents tumor DNA from moving into the bloodstream. The traditional way to understand the genomics of tumor progression is to operate on them, which can lead to increased risk of side effects such as bleeding in the brain and or infections.”
Liquid biopsies measure ctDNA in a patient’s blood and are already common for various forms of cancer. Because of the mechanism of the blood-brain barrier, they have so far been less utilized for patients with brain cancers. LIFU, however, temporarily disrupts how the blood-brain barrier works and allows tumor DNA to leak into the bloodstream, making them detectable in liquid biopsies. The patients enrolled in this trial have blood drawn before and after the non-invasive LIFU procedure. In addition, they all go through traditional, surgery. The results are then compared, and the investigators hope to be able to determine whether the ctDNA found in the patients’ blood corresponds to that found in the tumor cells that were surgically biopsied.
“For the patient, a LIFU liquid biopsy is a vastly different experience than having to go through a surgical biopsy,” said Michael W. McDermott, M.D., neurosurgeon and chief medical executive of Baptist Health Miami Neuroscience Institute, who conducted the LIFU biopsy on the first Florida patient. “This outpatient procedure, which is non-invasive, took two hours, and the patient felt great after. He was able to leave after six hours of monitoring. It is quite remarkable.”
The study is a prospective, multi-center, self-controlled, ongoing, pivotal trial evaluating safety and technical efficacy of LIFU for blood-brain barrier disruption (BBBD) to increase cfDNA in the blood of patients with glioblastoma. Before and after the procedure, phlebotomies and MRI of the brain are performed to evaluate outcomes. The primary study endpoint is defined as the ratio between their cfDNA level in the blood one hour after the LIFU procedure compared to the cfDNA level found in the blood before the procedure. The primary study hypothesis is that BBBD with LIFU leads to a two-fold increase in cfDNA in the blood. The secondary hypothesis is that there exists a 75% agreement between the biomarker pattern in the cfDNA sample from one hour post-LIFU and the biomarker pattern in tumor tissue obtained during the surgery.
“A huge benefit of a liquid biopsy is that the patient can receive cancer treatment as soon as the result of the liquid biopsy is available. After surgery, they often have to wait up to three to four weeks to begin treatment,” added Dr. Ahluwalia. “Ultimately, we hope LIFU liquid biopsies become an integral part of glioblastoma management. They may help measure treatment success or give clues when a therapy is not working, without having to go through invasive surgical biopsies that are associated with significant risk. It will also be a much less stressful experience for the patient.”
More information about this trial and how to participate can be found here.
About Miami Cancer Institute
Miami Cancer Institute brings to South Florida access to personalized clinical treatments and comprehensive support services delivered with unparalleled compassion. No other cancer program in the region has the combination of cancer-fighting expertise and advanced technology—including the first proton therapy center in South Florida, Latin America and the Caribbean, and one of the only radiation oncology programs in the world with each of the newest radiation therapies in one place—to diagnose and deliver precise cancer treatments that achieve the best outcomes and improve the lives of cancer patients. The Institute offers an impressive roster of established community oncologists and renowned experts, clinical researchers and genomic scientists recruited from the nation’s top cancer centers. Selected as Florida’s only member of the Memorial Sloan Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of a meaningful clinical collaboration that affords patients in South Florida access to innovative treatments and ensures that the standards of care developed by their multidisciplinary disease management teams match those at MSK. For more information, please visit cancer.baptisthealth.net/miami-cancer-institute.
Miami Cancer Institute is part of Baptist Health Cancer Care, the largest cancer program in South Florida, with locations from the Florida Keys to the Palm Beaches.
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