Y-90 Microspheres Medical Event in
Pennsylvania
Elaine M. Crescenzi, RT(N)
OAS Annual Meeting
Wednesday, August 27, 2014
Chicago, IL
Today’s Presentation
• Describe a medical event in Pennsylvania that involved
gastrointestinal shunting of Y-90 microspheres that resulted in a
bleeding ulcer and severe anemia
• Discuss issues raised by this event
Microspheres Brachytherapy
• Treatment of unresectable tumors in the liver
• Normal liver tissue is primarily supplied by the portal vein; liver tumors
are primarily supplied by the hepatic artery. Y-90 microspheres are
injected into the hepatic artery of the liver through a catheter.
• The microspheres flow into the liver tumor and become permanently
lodged in its blood vessels. The beta radiation destroys the tumor cells
from within the tumor, which reduces the impact to the surrounding
healthy liver tissue.
NRC Guidance for Microspheres
• “For the purpose of written directives and medical event reporting
requirements in the Y-90 microsphere guidance, ‘prescribed dose’
means the total dose (rad or Gy). Alternatively, prescribed activity
(mCi or GBq) may be used in lieu of prescribed dose.”
• “The written directive should specify the maximum
dose(s)/activity(ies) that would be acceptable to the specified
site(s) outside the primary treatment site due to shunting (e.g. lung
and gastrointestinal tract).”
• “The licensee shall record the administered dose/activity delivered
to the primary treatment site and to other specified site(s)…”
NRC Guidance for Microspheres
The licensee shall commit to report any event, except for an event that
results from intervention of a patient or human research subject, in
which:
1) the administration … of the wrong radionuclide
2) the administration of Y-90 microspheres results in a dose
a) that differs from the prescribed dose … by 20 percent
b) … to the wrong individual, via the wrong route, or by the
wrong mode of treatment; or
c) to an organ or tissue other than the treatment site that
exceeds by 0.5 Sv (50 rem) to an organ or tissue and by
50 percent or more of the prescribed dose/activity
expected to that site from the administration of
Y-90 microspheres, if carried out as specified in the
written directive.
Medical Event Reported to PA
•
A patient had a treatment of 36 mCi of Y-90 on 8/15/2013 for
tumors in the left lobe of her liver
•
She developed ulcer symptoms and was treated on 9/6/2013
•
She received two individual treatments of approximately 5 mCi of
Y-90 each on 10/10/2013 for two different locations in her right
liver lobe
•
Treatment for severe anemia was initiated on 2/26/2014. An
endoscopy indicated an ulcer in her duodenum. A biopsy sample
of the ulcer contained 55-60 synthetic beads
Medical Event Reported to PA
• On 3/10/2014, the licensee reported this event by telephone to
Pennsylvania
• On 3/11/2014, the state performed a reactive inspection
• No violations were identified
• Coordinated with Ohio to determine how they handled similar
events
• Coordinated with NRC to evaluate similar events in NMED
Issues Identified from this Event
• If an ulcer is found in the GI tract, and microspheres are inside,
what is the likely dose to the unintended organ? Greater than 50
rem?
• Is GI shunting an accepted risk of this procedure? Should these
incidents, when they occur, be considered medical events?
Questions
• What have your licensees been reporting?
• What have your inspections been finding?
• What do your inspectors emphasize during microspheres
inspections?
• Do your licensees perform imaging to prevent and evaluate GI
shunting?
Elaine Crescenzi, RT(N)
DEP Radiation Health Physicist
ecrescenzi@pa.gov
www.dep.state.pa.us
484-250-5835