ML18075A307

Summary of Teleconference Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)

ML18075A307
Person / Time
Issue date:	03/15/2018
From:	Office of Nuclear Material Safety and Safeguards
To:
Holiday, Sophie
References
Download: ML18075A307 (7)

Text

TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES February 15, 2018 MEETING

SUMMARY

PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Nursing Mothers Guidelines Subcommittees draft revised report on the recommendations on the cessation of breastfeeding for various radionuclides and the ACMUI Physical Presence Requirements for the Leksell Gamma Knife Icon' Subcommittees draft revised report on the recommendations for the physical presence of authorized users (AUs) and authorized medical physicists (AMPs) during treatments using the Icon' unit.

OUTCOME The ACMUI Nursing Mothers Guidelines Subcommittee provided a draft revised report for discussion with the full Committee. Subcommittee members included: Dr. Vasken Dilsizian, Dr.

Darlene Metter (Chair), Dr. Christopher Palestro, and Dr. Pat Zanzonico. During the meeting, the Committee unanimously approved the revised draft report with the modifications outlined below. The final report will be submitted to the U.S. Nuclear Regulatory Commission (NRC) staff by the end of March 2018. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the Committees recommendations in its continuing effort to make 10 CFR Part 35 more useful, practical, and not overly burdensome on licensees, while maintaining public health and safety.

The ACMUI Physical Presence Requirements for the Leksell Gamma Knife Icon' Subcommittee provided a draft revised report for discussion with the full Committee.

Subcommittee members included: Dr. Ronald Ennis, Dr. John Suh (Chair), and Ms. Laura Weil.

During the meeting, the Committee unanimously approved the draft revised report. The final report was submitted to the NRC staff on February 27, 2018. The NRC staff will consider the Committees recommendations for possible amendments to the 10 CFR 35.1000 Licensing Guidance for the Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon'.

A full transcript and handout for the ACMUI teleconference meeting can be found on NRCs public website at: http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.

The draft and final ACMUI Subcommittee reports are available on NRCs public website under ACMUI Subcommittee Reports: http://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.

AGENDA TOPIC

1. Discuss the Revised Draft Report of the ACMUI Nursing Mother Guidelines for the Medical Administration of Radioactive Materials.

2. Discuss the Revised Draft Report of the ACMUI Physical Presence Requirements for the Leksell Gamma Knife Icon'.

SUMMARY

The ACMUI Nursing Mothers Guidelines Subcommittee reviewed the radiation exposure from diagnostic and therapeutic radiopharmaceuticals, including brachytherapy, to the nursing mother and child. The Subcommittee recommended interruption periods for breast-feeding and for the close physical proximity of the nursing mother to the nursing child (i.e., caressing or holding the child with a similar distance to the mother as for breast-feeding).

The ACMUI Physical Presence Requirements for the Leksell Gamma Knife Icon' Subcommittee reviewed and evaluated the existing physical presence requirements for Icon' unit AUs. The Subcommittee recommended modifying the requirements such that AUs will be physically present (within hearing distance) at the initiation of treatment, but are able to be within a two minute walking distance to the Icon

' console area and immediately available to come to the treatment room. The AU will return to the console should there be any re-initiations and at the conclusion of the treatment to discuss any treatment or patient issues with the patient, physicist, and nurse. These recommendations are for the Icon' unit, in either the stereotactic frame or frameless mask mode.

RECOMMENDATIONS AND ACTIONS The Nursing Mothers Guidelines Subcommittee discussed the following recommendations in the revised draft subcommittee report:

1. For technetium-99m (99mTc)-labeled radiopharmaceuticals, rather than a radiopharmaceutical-specific interruption period, a single interruption period of 24-hours is recommended. Although this time interval may be longer than absolutely necessary for some 99mTc-labeled radiopharmaceuticals, it is compliant with the 100-mrem dose limit and simplifies the guidance, thereby avoiding confusion and reducing the likelihood of error.

2. For flourine-18(18F)-fludeoxyglucose1, all other 18F-labeled and all gallium-68 (68Ga)-

labeled radiopharmaceuticals, a 12-hour interruption period is recommended. This conservative recommendation is cautious and simplifies safety instructions for patients and medical professionals. A 12-hour interruption period is recommended for 68Ga for the following reasons: (a) a physical half-life comparable to that of 18F, (b) the propensity of free radiogallium to accumulate in breast milk and (c) the lack of relevant data on 68Ga-labeled agents in nursing mothers.

3. For very-short-lived positron-emitting radionuclides used in imaging, carbon-11 (11C)

(physical half-life: 20.4 min), nitrogen-13 (13N) (9.97 min), oxygen-15 (15O) (2.04 min),

and generator-produced rubidium-82 (82Rb) (1.27 min), no interruption in breast-feeding is recommended, since there is no significant activity remaining in the mother after the procedure is completed.

4. For iodine-123 (123I) in the form of sodium-iodide (NaI) (123I-NaI), an interruption period of 7 days is recommended. This is in marked contrast to the past, where complete cessation of breast-feeding for the current child was recommended. This older, more stringent 123I-NaI recommendation was largely based on contamination (up to 2.5% of 1 Fludeoxyglucose is commonly referred to as FDG.

the total activity) with long-lived iodine-125 (125I) (physical half-life: 60 days) that occurred with older methods of 123I production. Such contamination of 123I with 125I no longer occurs. Therefore, the restrictions on breast-feeding following 123I-NaI administration to the nursing mother may be justifiably relaxed to an interruption period of 7 days.

5. For gallium-67 (67Ga)-gallium-citrate, an interruption period of 28 days is recommended, which is consistent with the most conservative recommendations for 67Ga in the literature. For indium-111 (111In) labeled white cells an interruption period of 7 days and for thallium-201 (201Tl-chloride) an interruption period of 14 days are recommended.

These recommendations mirror that of the NRC in the Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, NUREG-1556, Vol 9, Rev 2, Appendix U, 2008.

6. For zirconium-89 (89Zr), a 28-day (i.e., 4-week) interruption period was set equal to the maximum recommended interruption period for 67Ga. The rationale for this recommendation are the comparable physical half-lives of 89Zr (3.27 days) and 67Ga (3.26 days). Both 89Zr and 67Ga are radiometals and may share some common chemical properties, and lastly, there is a lack of relevant data on 89Zr-labeled agents in nursing mothers.

For lutecium-177 (177Lu), based on the foregoing 89Zr rationale and a longer physical half-life (6.65 days), an interruption period of 35-days (i.e., 5 weeks) is recommended for 177Lu-labeled radiopharmaceuticals used diagnostically. For 177Lu-labeled radiopharmaceuticals used therapeutically, much higher activities are administered, and thus, permanent cessation of breast-feeding for the current child is recommended.

7. For radium-223 (223Ra) and all other alpha particle-emitting radionuclides, permanent discontinuation of breast-feeding for the current child is recommended. Alpha particles are densely ionizing, have high-linear energy transfer radiations that potentially incur far more significant biological effects than beta-particles, and are of particular concern in the young child in whom rapid growth and development are occurring. In the absence of relevant data and out of an abundance of caution, permanent discontinuation of breast-feeding for the current child is therefore recommended.

The Revised Draft Nursing Mother Guidelines for the Medical Administration of Radioactive Materials Subcommittee Report (ML18033B034) was unanimously approved by the full ACMUI with modifications to: (1) include recommended cessation periods for both 100 and 500 mrem limits; (2) acknowledge benefits of breastfeeding; (3) incorporate corrections as needed for gamma ray constants; (4) convert the units from conventional to SI units; and (5) correct references. The final report will be posted the ACMUI Subcommittee Reports Webpage by April 2018.

The Physical Presence Requirements for the Leksell Gamma Knife Icon' Subcommittee discussed the following recommendations in the revised draft subcommittee report:

8. The AU and AMP should be physically present during the initiation of all treatments involving the Icon' unit.

9. The current physical presence requirements for the AU can be modified by allowing the AU to be close enough to the console to respond quickly to any issue that arises, which is defined as within a two minute walking distance to the Icon

' console area, and immediately available to come to the treatment room. An AMP needs to be physically present during the entire treatment.

In addition to the AU and AMP, as a matter of good practice, we recommend that appropriately trained nursing or auxiliary staff be present during Icon

' treatment to respond to any immediate medical needs. It will be the responsibility of the AU to determine the necessary training and experience required of the nursing staff, who will be present throughout the procedure.

10. If there is an interruption of treatment secondary to medical or mechanical issues, the AU must return to the Gamma Knife Icon

' console to evaluate the patient and/or to review any mechanical issues. The AU must be present to ensure that the correct site is being treated during re-initiation of treatment.

11. At the conclusion of treatment, the AU must be present at the Icon

' console to discuss any treatment or patient issues with the patient, physicist, and nurse.

The Revised Draft Physical Presence Requirements for the Leksell Gamma Knife Icon Subcommittee Report (ML18033B033) was unanimously approved by the full ACMUI. The Final Physical Presence Requirements for the Leksell Gamma Knife Icon

' Report (ML18071A413) is posted on the ACMUI Subcommittee Reports Webpage.

Attachments:

1. List of Attendees

2. Agenda

MEETING ATTENDEES ACMUI Philip O. Alderson, M.D.

Chairman Pat B. Zanzonico, Ph.D.

Vice Chairman Vasken Dilsizian, M.D.

Member Ronald D. Ennis, M.D.

Member Darlene F. Metter, M.D.

Member Michael D. OHara, Ph.D.

Member Christopher J. Palestro, M.D.

Member Michael Sheetz Member John H. Suh, M.D.

Member Laura M. Weil Member Richard Green Non-Voting Member Zoubir Ouhib Non-Voting Member Megan Shober Non-Voting Member NRC Christian Einberg Acting, Deputy Director, Division of Material Safety, Security, State, and Tribal Programs (MSST)

Douglas Bollock Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Sophie Holiday Alternate Designated Federal Officer/ACMUI Coordinator Maryann Ayoade NMSS/MSST Jennifer Bishop RIII Said Daibes, Ph.D.

NMSS/MSST Jason Draper RIII Sara Forster RIII Cassandra Frazier RIII Michelle Hammond RIV Vincent Holahan, Ph.D.

NMSS/MSST Patricia Jehle OGC Jan Nguyen RI Patty Pelke RIII Gretchen Rivera-Capella NMSS/MSST Vered Shaffer RES Laura Shrum OGC Daniel Strohmeyer RIII Katherine Tapp, Ph.D.

NMSS/MSST Frank Tran RIII Lester Tripp RI Irene Wu NMSS/MSST MEMBERS OF THE PUBLIC Bette Blankenship American Association of Physicists in Medicine (AAPM)

Kelly Classic Mayo Clinic Charles Codleman VA Radioactive Materials Program

Thomas Conley University of Kansas Medical Center Whitney Cox Illinois (IL) Emergency Management Agency Robert Dansereau New York State (NYS) Department of Health Ariel Doucet Virtua Health Adam Ekstedt IL Emergency Management Agency Asfaw Fenta Virginia (VA) Radioactive Materials Program Michael Fuller VA Radioactive Materials Program Miguel de la Guardia Cook Childrens Health Care System Sandra Gabriel unaffiliated Jerry George Baptist Health South Florida Kimberly Gilliam VA Radioactive Materials Program Theodore Godfrey Elekta, Inc.

Bennett Greenspan Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Stanley Hampton Eli Lilly and Company Steve Harrison VA Radioactive Materials Program Desiree Kennedy Elekta, Inc.

Richard Kenney unaffiliated Tim Kleyn Indiana University Janaki Krishnamoothy NYS Department of Health Susan Lohman Elekta, Inc.

Lanchu Lu Ohio State University Medical Center Carol Marcus University of California at Los Angeles Richard Martin American Association of Physicists in Medicine (AAPM)

Barbara Matthews Baptist Memorial Health Care Corporation Catherine Perham Maine Radiation Control Program Richard Peros New Jersey Radioactive Materials Program Eric Perry Kentucky Radioactive Materials Section Michael Peters American College of Radiology (ACR)

Bruce Proctor Elekta.Inc.

Brad Read Elekta, Inc.

Slyvia Revell University of Texas Southwestern Medical School Daniel Samson NYS Department of Health Beth Schilke VA Radioactive Materials Program A. Robert Schleipman Partners Healthcare Lou Shimabuku unaffiliated Eugenio Silverstrini Northwell Health Michael Stabin Vanderbilt University Cindy Tomlinson American Society of Radiation Oncology (ASTRO)

Michael Welling University of Virginia

Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Thursday, February 15, 2018 9:00 AM - 11:00 AM (ET)

OPEN SESSION 9:00 - 10:00 am Discuss the Revised Draft Report of the ACMUI Nursing Mother Guidelines for the Medical Administration of Radioactive Materials 10:00 - 11:00 am Discuss the Revised Draft Report of the ACMUI Physical Presence Requirements for the Leksell Gamma Knife Icon'