Washington is one of first states to license promising new cancer treatment
DOH helps clear the way for Alpha DaRT trials in our state
In fact, the treatment shows such promise that the federal Food and Drug Administration (FDA) is granting it “breakthrough device status.” This means that clinical trials — scientific studies with patients on safety and effectiveness — can move forward quickly.
And Washington is one of the first states to authorize its use in those studies. Our role at DOH is to make sure patients are safe.
Here’s the story of how it came together.
The science behind the discovery
Alpha Tau Medical, a company in Israel, developed a new way to treat a certain type of tumor called a hard tumor. Breast cancer, bone cancer, lung cancer and prostate cancer are types of cancer (“solid cancers”) that involve hard tumors.
The treatment is called “Alpha DaRT” (Diffusing Alpha-Emitters Radioactive Therapy). It involves inserting a metal “seed” into the tumor. That seed uses tiny particles of radium to try to break down and shrink the tumor.
Dr. Tristan Hay of DOH said that AlphaDART is a new type of “brachytherapy.” This approach treats solid cancers — like skin cancer — by using radiation in or close to the tumor. What’s different about AlphaDaRT is that the radiation has a better chance of hitting and destroying cancer cells.
This procedure would replace invasive surgery. It could also take the place of external “beam radiation” therapy, where a medical specialist uses a machine to aim a beam of radiation from outside your body to the affected area, explained Dr. Hay.
“This new treatment makes for an easier treatment with less hassle for the patient and doctors,” he said.
Currently, it’s only available in clinical trials. In Washington, the trials are for skin cancer.
Protecting Washington patients is our job
To use the treatment in a clinical trial, medical facilities must get a special type of license. Dr. Hay, one of our nuclear medicine specialists, worked with the federal government to set guidelines for who should use the technology and when.
“To get this treatment to patients, I worked with Nuclear Regulatory Commission medical staff and other local medical physicists to determine exactly how to license this product,” Dr. Hay said. His medical physics background helped him understand the important health and safety issues that could be involved, and how to address those in the licensing process.
When a medical facility uses radioactive material like this, it’s crucial to keep the providers, patients, and the public safe. That’s our role at DOH, says Dr. Hay.
With Alpha DaRT, there is an added step: Physicians need to be trained on how to use the new procedure.
“Training physicians and ensuring safe handling of Alpha DaRT seeds is part of our job as state regulators,” Hay said. “The radiation should only go where it needs to go, while keeping others involved safe.”
As of late June, two medical facilities in our state were licensed to take part in the trial and perform the procedure.
The benefits to patients
“If the trial is successful, the product can be fully authorized by the FDA and become a routine treatment,” Dr. Hay said. “The manufacturer also wants to use the product to treat different types of cancers in future trials.
“This is another promising weapon in the fight against cancer.”
This is just one of the many examples where we help make cutting-edge medical technology available to people in Washington.