Over the past few years, the imaging community has had a whirlwind of technological advances and the introduction of a handful of new imaging agents, especially in the PET/CT space. In this article, we will explore one of the more impactful PET/CT imaging agent that will soon be available in most major markets, Cerianna (fluoroestradiol F18).
What is Cerianna
We have recently witnessed the introduction of many new imaging agents within the nuclear medicine community, specifically within the PET/CT space. From Axumin to NETSPOT, it’s been an exciting few years, but the momentum has not stopped there.
This past spring, Zionexa USA and PETNET Solutions, Inc., a Siemens Healthineers company, announced that the FDA had approved Cerianna (fluoroestradiol F18) for PET/CT imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
This announcement marks the first time the FDA has approved a PET imaging agent specifically-indicated for use in patients with metastatic or recurrent breast cancer.
Estrogen Receptor (ER)-positive Breast Cancer – by the Numbers
It is estimated that 1 in 12 women in the United States will develop some form of breast cancer and that over a quarter-million breast cancer diagnoses are made each year. The American Cancer Society estimates that roughly two out of every three breast cancer cases are hormone receptor-positive.
Many of these cases tend to be ER-positive, which means that the impacted cells’ surface has estrogen receptors. Typically, but not always, this type of cancer responds well to hormone therapy and depends on the severity and extent of the disease state when the patient is first diagnosed.
How Does Cerianna Work?
The future for ER-positive breast cancer patients has gotten significantly better, with better ways to detect the disease. Unlike traditional imaging methods that rely on blood flow to a specific area to create a contrast-enhanced image or cellular metabolism for an FDG PET/CT scan, Cerianna utilizes the hormone receptors on the surface of the cells for localization.
So what does this mean? Imagine the hormone receptors on the cellular surface as pad-locks and the Cerianna as a bundle of keys. When injected into the bloodstream, the keys (Cerianna) circulate throughout the body in search of locks (hormone receptors). Once the key (Cerianna) finds the lock where it fits (hormone receptor), it will attach itself to the surface of the cell.
This lock and key mechanism or receptor binding mechanism, allows medical professionals to visualize where the ER-positive breast cancer is within the patient, regardless of location. When imaging occurs prior to a biopsy, the physician may be alerted to a previously unidentified area that is more accessible for a biopsy, which provides a higher confidence level in their ability to obtain a quality tissue sample.
How Do I Make This PET/CT Exam Available For My Patients?
While the details are still being worked out, one thing we know for certain is that you will have to work with PETNET to obtain the radiopharmaceutical; they have an exclusive agreement with Zionexa for distribution.
PETNET estimates that the imaging agent will become available for the majority of the US in late 2020 into early 2021. Now is the time to work with your local radiopharmacy to address all of the important details – billing/coding, reimbursement, ordering, RAM licensing (if needed), gauging physician interest, etc.
As we have seen with other imaging agents, it is crucial to implement this imaging agent as soon as you can; otherwise, the neighboring hospital or imaging facility will, and it may be challenging to disrupt the referral pattern once established.
What’s Next for Cerianna
While we have witnessed the introduction of many newer imaging agents in the nuclear medicine and PET/CT industry, we must learn from the past. Many of these imaging agents can have a positive impact on patient treatment planning and should be implemented.
While it is uncertain what the future holds for long-term reimbursement, it is suggested to utilize Cerianna while it is covered under the pass-through status. Those who wait may have a tough time to disrupt the established referral patterns, and the reimbursement landscape may have changed (Axumin and NETSPOT have both recently lost their “pass-through” status, making it difficult for some PET/CT departments to justify using the imaging agents).