Hyperpolarized Metabolic MRI Imaging:
Over 1,250 studies world-wide & counting!
By Jean-Luc Vanderheyden, PhD, JLVMI Consulting LLC
In 2022, despite COVID significantly limiting patient enrollment and impacting availability and manufacturing of critical parts, the 15 clinical sites world-wide progressed to conduct a great number of human studies in multiple ways.
First, an additional 226 studies were completed in both patients and volunteers between 1 JAN and 31 DEC 2022, bringing the total number of studies to 1,286 overall the years and the number of individuals evaluated to 863. Like last year, on average, 3 out of 10 studies involved volunteers.
Many of these studies represented multiple injections, as can be seen from the table below, which has been expanded to capture 2, 3 and 4 or more injections in the same subject, with a significant percentage (greater than 50%) of repeated studies allowing test/retest and follow up of responses to therapy. This also attests to the high safety profile of the formulation prepared for each injection. Only self-reported mild side effects associated with the injection and no moderate or severe adverse events even after multiple administrations to the same subject were reported.
The applications have remained focused on cancer patients, with prostate, brain and other solid tumors, but cardiology has gained high interest, both in evaluating the critical issue of chemotherapeutic cardiac toxicity as well as in diabetes research.
Sites have now migrated to an improved Part B with the appropriate qualification runs and have smoothly transitioned in the clinic, allowing the combination of multiple probes imaging, such as C-13 Pyruvate in the C-1 and C-2 positions. A major milestone was accomplished by the UCSF team in their co-injecting of hyperpolarized C-13 Pyruvate and [13C,15N2]urea, ushering a new era of development. More probes are now in development, their quality control facilitated by an MPQC (multi-probe quality control) unit that showed flexibility at an astonishing speed with the partial release of a drug product in a matter of seconds!!
Over 76 publications describing human studies and clinical implications of hyperpolarized C-13 Pyruvate were authored and released to date, serving as a repository of key information for future users!
Congratulations to all those involved and the 15 sites that globally exploit the technology for better understanding of fundamental science and leading towards unmatched clinical applications.
