FDA approves Mayo's PET radiochemistry facility in Florida

FDA approves Mayo's PET radiochemistry facility in Florida

John R. Fischer, Staff Reporter | September 23, 2019
Molecular Imaging
Mayo Clinic's PETtrace cyclotron from GE Healthcare
The FDA has given the green light for Mayo Clinic’s positron emission tomography radiochemistry facility in its northeast Florida location.

Located in the Robert and Monica Jacoby Building, the approval makes Mayo Clinic the only academic center in the region to house a cyclotron facility available for patient care. It is also the last installation of a cyclotron at all three of Mayo Clinic’s campuses.

"The PET Radiochemistry facility, which houses the cyclotron, will be producing currently FDA-approved radiotracers and new research radiotracers for diagnostic imaging of cancer, dementia and cardiac diseases,” Dr. Manoj Jain, chair of nuclear medicine at Mayo Clinic in Florida, told HCB News. “These imaging radiotracers can help in application and development of future therapy agents, which are usually produced and delivered from nuclear reactor facilities.”

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The cyclotron facility will produce a range of radiopharmaceuticals, including carbon-11 choline for imaging recurrent prostate cancer and fluorine-18 labeled glucose for cancer, cardiac and neurological imaging. Others include nitrogen-13 ammonia for cardiac imaging; and fluorine-18 sodium fluoride for skeletal metastatic disease.

It is the only facility in Northeast Florida to offer investigational emission tomography radiopharmaceuticals for research and clinical practice use, with the drugs required to be administered within minutes after being produced due to their short half-lives.

Jain says that among its research endeavors will be work supporting the experimental practice of theranostics, a precision medicine approach for determining targeted therapies based on specific targeted diagnostic exams.

“The currently performed Theranostics at Mayo Clinic Florida is for metastatic neuroendocrine tumors, and the process involves selection of eligible patients using a multispecialty team approach. This 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) therapy was approved by the FDA on January 26, 2018,” he said. “We will be performing about 100 therapies this year. The upcoming Theranostics is for metastatic prostate cancer, for which there are ongoing multicenter trials, but still awaits FDA approval.”

The expansion was supported by a $10 million gift from Robert and Monica Jacoby.

The first phase of that expansion included more than $300 million in construction, including the cyclotron facility.

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