The iron oxide nano particles, antigens and Imagion's stealth coating have all been approved for use in vivo. This 1st clinical trial will not require a human sized Magsense instrument. This trial is for Her2 metastatic breast cancer patients who are scheduled to have the sentinel lymph node removed. Prior to surgery, they will be injected with the iron oxide nano particles with the tumor targeting antigens and stealth coatings attached, and at distinct time intervals, they will then be surgically removed, tested at MD Anderson or possibly another location (sight selection still ongoing) using the existing small animal magsense instrument all ready on site at MD Anderson, and after the magsense gets it's scans, the pathologist while then dissect the lymph node and compare results with the magsense scans. If the results are satisfactory, one could assume, Imagion would then immediately apply for early cancer detection in humans trials ( the pivotal study ) and then expedite completion of the human sized magsense instrument, which would be needed for this clinical study.
The first in human study should take place mid 2020 and last a few weeks, with results announced while the study is on going. I for one wish them the very best of fortune and God's speed. Good luck to all!
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