Destroying Liver Tumor with Sound Waves: Baptist Health First in S. Florida to Use Non-Invasive Tech in Clinical Trial

A 72-year-old man diagnosed with liver cancer was the first patient in South Florida to have his tumor destroyed by high-intensity, focused ultrasound pulses. The non-invasive technology, called histotripsy, may sound a bit like science fiction.

However, it’s becoming a reality thanks to the #HOPE4LIVER trial, in which Miami Cardiac & Vascular Institute and Miami Cancer Institute, both part of Baptist Health, are taking part, enrolling patients who have liver tumors and are candidates for histotripsy. Baptist Health is one of eight sites taking part nationally in the study, led by Govindarajan Narayanan, M.D., chief of interventional oncology at Miami Cancer Institute and the principal investigator in the #HOPE4LIVER trial study at Baptist Health.

“Histotripsy is the first image-guided technique to harness pulsed sound waves to target tissue, such as a tumor, completely noninvasively — without heating and without the use of ionizing radiation,” said Dr. Narayanan. The technology does not yet have approval from the U.S. Food and Drug Administration (FDA). But the trial is a crucial step toward gaining final FDA approval.

The Edison platform from HistoSonics, with robotic arm, delivers pulsed sound energy into the body without any incisions or needles, and can destroy cancerous tissue at the sub-cellular level. Physicians can visually monitor the effects in real time.

“It’s completely non-invasive and that is really the beauty of it,” explains Ripal Gandhi, M.D., an interventional oncologist at Miami Cancer Institute and a vascular interventional radiologist at Miami Cardiac & Vascular Institute, who is co- investigator in the #HOPE4LIVER trial. “So, you have this ultrasound probe, which is placed on top of the patient, but there’s no needles –there’s nothing invasive going on. And it utilizes this focused ultrasound to actually mechanically destroy the tumor. And that’s really the beauty.”

The procedure was a complete success. Dr. Gandhi led the team that performed the procedure, which included Constantino Pena, M.D., an interventional radiologist and Medical Director of Vascular Imaging at Miami Cardiac & Vascular Institute; and Brian Schiro, M.D., vascular/interventional radiologist at Miami Cardiac & Vascular Institute.

“They had done an MRI before the procedure, but part of the protocol is to get another MRI within 36 hours of the procedure,” said Dr. Gandhi. “So, we did an MRI the next day and the MRI shows no evidence of viable disease, it looks completely destroyed.”

There is much promise that this technique can help destroy cancerous tumors in other organs, says Dr. Gandhi. But if it’s successful with liver tumors alone, that would be a significant advancement for many cancer patients. That’s because liver cancer rates are on the increase in the United States. And other than lymph nodes, the liver is the most common location for metastatic cancer — or cancer that has spread from elsewhere in the body.

“This treatment is not just for primary liver cancer, it’s also utilized to treat metastatic liver cancer, which can be from any site,” explains Dr. Gandhi. “It can be from colon cancer, from breast cancer or from any other organ. And when you talk about metastatic disease, the liver is the second most common site of metastatic disease.”

Histotripsy, developed by HistoSonics, originated with ultrasound scientists from the University of Michigan who were working on a non-invasive potential alternative for certain surgical procedures. HistoSonics has worked with the FDA for more than three years in developing pre-study clinical data. The FDA has granted the company Breakthrough Device Designation for its new therapy platform, enabling the #HOPE4LIVER trial to move forward. 

Only about 25 percent patients with liver tumors are eligible for surgical resection because of the presence of multiple tumors, or underlying poor liver function, or general health issues limiting the prospect of surgery. In the case of the Baptist Health patient, Dr. Gandhi explains that he could have undergone a percutaneous ablation procedure.

The ablation procedure involves “putting needles directly into the tumor and burning the tumor away, he said. “And there’s always a risk of bleeding, that’s one of the potential complications, although risk is low, it’s something that can happen,” said Dr. Gandhi.

The advantages of the histotripsy technology include a quicker recovery for the patient. For physicians, the procedure is linked to a large computer monitor from which they can monitor the destruction of tissue under continuous real-time visualization and control. A robotic arm does the work of emitting the pulsed sound waves.

Essentially, the sound waves create microscopic bubbles within the tumor’s cells, which cause these cells to rupture and die. Any “debris” left behind is gradually absorbed and disposed by the body’s normal processes. While there is hope that the technology can be expanded to other cancerous tumors, there are many patients that can benefit from its current function of targeting the liver.

Explains Dr. Gandhi: “This technology has the potential to positively impact so many patients because there’s so many patients who have cancer, which could be in any part of the body, but at some point may involve the liver.”