Disclosures. I am on the Onyx speaker bureau I am a paid consultant to. Boston Scientific CeloNova Cook MDS Nordion Sirtex

Transcription

1 Disclosures I am on the Onyx speaker bureau I am a paid consultant to Boston Scientific CeloNova Cook MDS Nordion Sirtex

2 Comparing Y90 Devices Matthew S. Johnson MD, FSIR Indiana University School of Medicine

3 Yttrium 90 -laden microspheres Yttrium 90 Pure beta emitter Half life 64.2 hours Effective range in tissues of ~2.5 mm Decays to zirconium 90

4 The Devices SIR-Sphere (Sirtex) Therasphere (Nordion)

5 SIR-Spheres Delivered as a vial containing 5 ml water and million microspheres with total activity* of ~3 GBq (81 mci) 90 yttrium (Y90) Resin microspheres are microns in diameter The average activity per sphere is ~50 Becquerel (Bq)

6 Theraspheres Delivered as a vial containing 0.05 ml water and million microspheres with (original) activity of 3-20 GBq ( mci) Glass microspheres are microns in diameter The average activity per sphere is 2500 Bq

7 Approval SIR-Sphere granted Pre-Market Approval (PMA) by the FDA on March 5, 2002 This device is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic chemotherapy (IHAC) of FUDR (Floxuridine)

8 Approval Therasphere granted HDE H December 10, 1999 For radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters.

9 Major Practical Differences Approval SIR-Sphere has PMA approval in conjunction with IHAC FUDR use is usually off-label Therasphere has HDE approval Requires IRB oversight At IU, requires documentation of discussion of Therasphere s HUD status with patient, strict adherence to protocol for use, signed study consent, document storage, scheduled reporting to IRB

10 The Spheres TS are composed of glass and yttrium Produced by bombarding ampoules of nonradioactive Y 89 with neutrons in a nuclear reactor Specific gravity is ~3.6 SS are composed of resin to which Y 90 is bound Y 90 is extracted from a Strontium 90 generator Specific gravity is ~1.6

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13 The Spheres Activity Y90 throughout (TS) versus on the surface of (SS) the MS yields ~50 times more activity/sphere Contaminants Theraspheres contain trace Eu 152 t½ ~ 13.6 years SIRSpheres may contain Sr 90 t½ ~ 28.8 years Affect how residual material must be stored May affect morticians and disposition of remains

14 Evaluation and Management of Patients with Liver Cancer The 5 step process Labs and Imaging Diagnosis, consideration for Y90 Referral to IR Clinic IR Clinic Visit, Discussion of Options Planning and Staging Arteriographic Procedure (with Tc-MAA injection and Imaging) dosimetry Y90 Administration Procedure F/U, Evaluation, Additional Therapy

15 Major Practical Differences Device Deliver/Dosimetry Calculation SIR-Sphere Calibrated to be 3 GBq at 1800 on the day of after delivery to you (as of August 3, 2010) Delivered to you on Tuesday, Wednesday, or Thursday NM technologist draws up activity requested through written directive and gives to IR As such, administration can be scheduled at any time on Tuesday, Wednesday, Thursday, or Friday

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18 Major Practical Differences Device Deliver/Dosimetry Calculation Therasphere Calibrated at noon the Sunday 1-12 days before administration Requested activity (as determined by prior dosimetric calculation) is delivered > a day in advance for use at a particular day and time Entire dose is used Delivery can be Monday through Friday, but day and time of delivery are determined by dosimetry

19 Spreadsheet created by David Agarwal, MD

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23 Major Practical Differences Preparation and Delivery Desired percentage of SIR-Spheres is pipetted from delivered vial by Nuclear Medicine personnel Entire vial of Theraspheres is delivered; no fractionation at site is required

24 Major Practical Differences Dosimetry Calculation SIR-Sphere dosimetry assumes that tumors receive 5 times the dose of hepatic parenchyma suggested dose delivers less than 50 Gray to parenchyma Suggested Therasphere dose is Gray to the treatment volume

25 Evaluation and Management of Patients with Liver Cancer The 5 step process Labs and Imaging Diagnosis, consideration for Y90 Referral to IR Clinic IR Clinic Visit, Discussion of Options Planning and Staging Arteriographic Procedure (with Tc-MAA injection and Imaging) Y90 Administration Procedure F/U, Evaluation, Additional Therapy

26 Current IR Y 90 AU Application Process (35.390[b][1][ii] Continued) (A) (B) (C) (D) (E) (F) (G) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters Calculating, measuring, and safely preparing patient or human research subject dosages Using administrative controls to prevent a medical event involving the use of unsealed byproduct material Using procedures to contain spilled byproduct material safely and using proper decontamination procedures [Reserved] Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status

27 Becoming an AU: Current Status 2. Obtain certification that you have successfully performed Y 90 radioembolization-specific training by either: a. 3 supervised hands-on cases by an existing AU, or b. 3 supervised hands-on in-vitro simulated cases by the Y 90 manufacturer

28 Major Practical Differences Initial Treatments Sirtex Onsite clinical proctoring of first three cases MDS Nordion Therasphere University at Northwestern Company representative present for first three clinical cases

29 Major Practical Differences Delivery Apparatus Method of Delivery

30 Therasphere Delivery

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32 Therasphere Delivery

33 SIR-Sphere Delivery

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36 Major Practical Differences Delivery Apparatus, method (my experience) Full Therasphere dose is delivered in under 5 minutes SIR-Sphere administration usually takes (me) around 30 minutes ~99% Therasphere dose is usually delivered >95% SIR-Sphere dose is usually delivered

37 Major Practical Differences Delivery Size and volume of particles million micron (mean /- 2.5 microns) SIR-Spheres X dose (GBq)/3 GBq million micron Theraspheres

38 30 microns Therasphere SIR-Sphere

39 30 microns

40 Major Practical Differences Delivery SIR-Spheres are larger and there are more of them slowing of flow/stasis in the target vessel may occur, especially with Segmental left hepatic arteries Relatively hypovascular tumors

41 Major Practical Differences Delivery Stasis is never seen with Theraspheres Fewer, smaller particles You don t perform arteriography during Therasphere delivery

42 Major Practical Differences Delivery Failure to deliver 80% of the dose prescribed in the written directive must be reported to the Nuclear Regulatory Committee* And they will come to investigate *unless stasis were reached

43 Minor Practical Difference Dividing Dose SIR-Sphere: pipette two doses from vial Therasphere: order two doses for delivery at same time

44 Advantages (My View) SIR-Spheres PMA Does not require IRB oversight Does not require delivery at pre-set time to achieve prescribed dose Unlikely to fail to deliver >80% dose without stasis Theraspheres Available for use Monday-Friday exposure to personnel Faster delivery Less embolic Decreased incidence of non-target embolization [portal vein occlusion] [variant/small arteries]