The Medical Use of Radioisotopes Recommendations and Requirements by the Atomic Energy Commission

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TABLE OF CONTENTS 1. Diagnosis of thyroid function--------------------- 2. Determination of blood volume and plasma volume--- 3. Diagnosis of other clinical con2itions------------ 4. Treatment of hyperthyroidism and/or cardiae

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The present procedurcs of t,he atonic Energy Camiission for the allcc.atj.on of radioisotopes for medical rescarch, diaenosis and the rap j are set forth isotope training nrid expr ien ce for use of radioisotopes i n humm subjects have been established i n advisement with t h e Subcommittee on Human A?plications of the Atomic Energy Cmmissionts General Advisory Committee on .‘ in this announcement. The rccormendat,ions for ninbum clinic el radiocians and typify the nature rather desirable clinic el radioisotope experience. For special si.tuztionsa other experience nay serve i n lieu of the particular recommendc.tionS ,set forth in this announcevent, I n considering such applications, the Atcmic Energy Commission i s concerned primarily with matters of radio l cgi cal health s,lfety, Toward this end the CormiEsion seeks t o determine ifthe appU.can% has equipment and facilities Zppropriatc t o the proposed use nnd whether the physician is trained in basic: principles of radioactivity and has specific experience inthe use of radioisotopes in the clinical situ rt ions being proposed, The information i s indicated by the applicant on his application form and the supplemcntary sheets attached thereto.

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Upon favorable review of the application (See NOTE below), I 1;-Form AEC-374, "Byproduct Material License," i s issued. This license permits the holder t o procure radioisotopes i n accordance with the conditions stated on the application and license forms and in Title 10 of the Code of Federal The Isotopes Extension normally reviews applications proposing new o r nonroutine medical uses of radioisotopes i n collaboratiorl with the Advisory Subcommittee on Human Applications, usually requires four weeks for completion, The recommendations and requirements established by the Atomic Energy Commissior, for the clinical use of radioisotopes a r e designed t o provide for two types of medical radioisotope programs. These are defined a s follows8 1, Institutional Medical Radioisotope Program Clinical radioisotope programs established by a medical institution and carried out under the guidance of a medical isotopes comniittee (See recommendations f o r membership and duties of a medical isotopes cod tte e i n Section IV, A. Page 6) are designated as " In st it u - that the physician(s) naned on the license form supervise the conduct of the program with the guidance of the medical isotopes committee. radioisotope(s)shall be by, orin the presence of or under the supervision of on the license and confined t o the location and the purposes in dice ted thereon. Licenses for institutional use require The use of t h e

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NOTZ 1: i%ysZcians other than tkcsc? named on the lfzcrise form may participate in tho medical radioisotopes physicirr.s and up msp prc val by the medical isotopes vehicle !Thereby physj cions other thar, those named on an license may have En opportunity t o gain radioisotope experieccc caimensurate with t h e recommendations ir. this announcemento Such eq erie n ce may assist these physicj Ens i n in5 :.l.ating cal program operatTd under the guidance of a medical isotopes cormittee ;re discouraged from in it ic ting separate zp?licaticns for use of radioisotopes i n s pcc if ic clinical program where the institution already holds a license (porn! &?C-374) for such experienced in the use ora radioisotope fora particlilar c lln ical situation be designated by the medical is ot qes co.m:I.itze as the zominally responsible Subject to the apr ov nl of the medical isotQpes committee &,her staff ;:hysicians may ad n in is ter radio - isotopes t o pztierits in cu csu lt ation with or ur,dsr the supervision of the physician(s) designated on the license Tom as mmti.or,ed i n NOTE 1 ahove. It i s rcconliieridec~that one o r nore physic hn s a physician Inhis individual practice without, the guidance of ;; rnedical isotopes conulittee are designated as vt in divi bu alp rect ice 'l'h3-w progrms are limrted t o

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well-established medical uses of radioisotopes. for the use of rcdioisotopes in individual practice - requfre that the phgsician(s) s o licensed personalllcarry out the program. Such use shall be confined t o the location, dosage and purposes indicated on the license E. Supporting Information t o Accmpany Applicztion 1. Apelications for " institut jon d use" should provide the supporting information described i n Sections I -111, I V and -V of this announcement. 111. GDERAL PEXJUIREPENTS FOR MEDICAL USE OF XADIOISOTOPES A standsrd preceptor forni has been preinred by the Isotopes Extension as a convenient mezns of furnishing information concerning the physician's basic radioisotope tr airing and clinical. experience inthe use of radioisotopes. cian should have his medical preceptor in the clinical radioisotope work proposed forward a conpieted V receptor Statement" to the Isotopes Extension with his initial appliinclude 'other clinical situ at i0r.sa new preceptcr form noma1 should be submitted if information concerning h i s experience i r ? these niedical uses has no% previously been provided. When a physician wishes t o extend his program t o Every applications hall include the proposed dosage range for e il cho f- the diseases or ccnditions t,o be followed, j-sot,ope i s proposed for both diagnosis and therapy, the dosage range for each isto bc stated spparatelp. (in milli curies or microcuries) per single administration i s t o be indicated as well as the number and frequency of such The approximate dosage

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- Applications proposing such experimental o r nonroutine uses of radioisotopes i n hwnan subjects should be supported by a statement detailing the rationale for the dosage proposed and other data asset forth under Section V.EDO Page 14C. Prerequisites for Use 1. The individual t o use radioisotopes i n human subjects shall be a physician licensed t o dispense drugs inthe practice of medicice by a state or territory of the United States,the District of Columbia orthe Commoflwealth of ? uerto Rico. 2. Normally the proposal t o use radioisotopes i n human subjects should be appropriate tothe scope ofthe physician f s medical experience, specialt,y and/or board 3 . The physician should have personal experience gained ~ rt ici pat lo ns hall be obtained by collaborating in a procram using radioisotopes i n clinical situations canparable to those proposed i n be i n accordance witn the recammendations cited under Clinical Radioisotope Eyperience for use of Radioisotopes . m The training and experience should a. Basic radioisotope training x shall provide the physician a working knowledge of 1, Principles and practices of radiological ? e Radioactivity niea surern ent standardi z ati on and monitoring techniques and instruments. 3 . Mathematics and calculations basic to the use and measurement of radioactivity, h. Biological effects of radiation, Actual use of radioisotopes inthe types and quantities for which application is being made, * Satisfactory completion of the Oak Ridge Institute of Nuclear Studies "Basic Course i n Techniques Using Radioisotopest1 orits equivalent Hill serve a s evidence of compliance with requirements in basic tre fn in go

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B o Active Participation Consists of 8 1. Evaluation of the suitability of the patient for radioisotope r ' , diagnosis and/or treatment by taking patient his to des and performing medical examinations and/or study of case histories, 20 Collaboration i n diagnosis axI,/or treatment and dosages prescribed, h0 Related measurements aad pl@tt,i.ng of data 5 , Active period of training ar;d e,Gsrience of sufficient duration t o permit the following or" specific patients th rou gl treatment and post-treatment periods, inch ding reevaluation as to effectiveness end cmp li cat fo as, 60 Study of case histories (wibhaut seeing ? at i ents), 80 Observation and discussion of diamostic and/or therapeutic technlques, as well A S management, of patients during follow- -NOTE% Details of the physicians active participation should be indicated by his niedical preceptor on the standard preceptor fom discussed in Section III A, page 4. I V o SPECIAL REQUIRENENTS FOR INSTITUTIONAL MEDICAL PROGRAM -(See also General Requirements cited undw Section P1119 above) The applicant institutions hall appoint a medical isotopes .ca ~ s ~ itte ets evaluate all proposals for research, diagnostic and therapeutic use of radioisotopes within the institut Lon, The in it id.application from an institution should include the names, specialties, and pertinent radioisotope experience? i f any, ofthe members of the medical isotopes emunittee, The functions of the committee, as well as the administrative procedures by which it c a r r i 2 s GU$ these functions, should also membership of t h e T,anmit-tee should be described, I n subsequent, applications any chailges i n +,he

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-XOTEx Where the use of radioisotopes ina medical insti - tut ionis to be limited t o sealed radiation sources for well. esteblished intra cav itz ry,interstitial or external therapeutic procedures, a Redical isotopes committee is not necessaryc See Section _I_V I I I , Page 2 3 0 1. Formation of a Medical Isotopes Cdt tee The Medical Isotope Committee shsll include atleast three members. Membership should inc1ud.e physic i as expert in internal medicine (or hematology), pathology, or therapeutic radiology and i! person experienccd i n assay of radioisotopes and protection against ionizing physicist be available to the Comriittee, atleast in a It is often appropriate thata quali€ied It is recognized that the composLtion of local isotopes committees may vary from institut im to institution depending upon the individual interests of a partj.cular 2. Duties of t h e Med.ica1 Isotopes Committee Generally, the Committee should have thef o11oi:ing a, Review and grant permission for y Gr disapproves the use of radioisotopes within the in st ltu t4on from the standpoint of radiological health safety and other factors which the Cm!nit,tes may wish toes tab ll sh for medical use of these b, :?rescribe special conditions which may be necessary, such 8 s yhysicgl examirations, adzkition21 tri:bning, desigriation of limited area or loc atl cr, 0.: USCg disposal methods, etc, C . Review records and receive reports from the radiological safety off Icer o r other ir,divid.usl

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do Recommend remedial action when a person fails t o observe safety recommendations and rule so Keep a record of actions taken by the Committee. i' Radi materials distributed by Atmic Energy Commission-owned laboratories are not necessarily of pharmaceutical quality and are not warranted as to identity,quality or quantity. An applicant desiring to procure radian ate rials for human use, therefore, must either purchase them preassayed and of pharmaceutical quality from commercial concerns o r process them himself should he choose t o receive these materials from Commission laboratories. Where the latter option is chosen, the applicant should include with his application the following information: 1. His experience i n standardization and measurement 2. The procedures t o be employed for identifying and assaying the radiomaterial and carrying out such other testing and processing (sterilization, pyrogen tests, etc,)as may be appropriate. 3. The instruments and equipmont available for this purposeo -NOTEx When purchasing radiomaterials from an AEC distributor (e .go Oak Ridge National Laboratory), all non-federal applicants must use a special "Isotope and Service Irradiation Order Formtt (Form AEC-391) and federal agencies must use an these forms are available from the AEC distributors and Isotopes Extension. These forms a r e not intended for use when ordering materials from other than AEC distributors, INSTITUTIONAL USE (In acld.ition tothe requirements dfscussed i n Section 111 C., Page 5, the physician should have clinical radioisotope experience commensurate with the following rec mend ation(s) applicable to the use(s) proposed on his application, I, D iq nos is of Thyroid Function The physician should work f o r et leas'i, 30 program where Iodine 131 f o r diagnosis of and treatment o f thyroid disease is being

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During the 30-hour period of time t h e physician should actively participate in such diagnostic studies in at ._INOTE: The Iodine 131 unless otherwise exempted, shall be procured in precisely calibrated farm. 2, Determination of Blood Volume and Plasma Volume The physician should work for atleast 30 hours i n a medical program where Iodine 131 for blood During the 30-hour period of time t h e physician should actively participate in 10 such blood determinations, Physicians already using Iodine 131 i n diagnosis of thyroid function can qualify after active participation i n 3 such blood determinations, NOTE: The Iodine 131 unless otherwise exempted shall be procured i n rl sterilized,precisely calibrated 30 Diagnosis of other Clinical Conditions The use of Iodine 131 for the localization of brain tumors, hepatic malignancies, etc ,, represents specialized applications requiring considerable refinement i n techniques and specialized instrumentation.' The use of radioiodine for these purposes i s normally limited to physicians alreedy having subs tant idl experience i n both diagnostic and therapeutic use of radioisotopes as well as specific experience i n the modality being proposed,

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Applications proposing such use of radioisotopes should be supported with information describing the clinic a l. - procedures t o be followed and the instrumentation t o 4 0 Treatment of Hyperthyroidism and/or Cardiac Dysfunction The physician should actively participate in the use o f ' Iodine 131 for the treatment of hyperthyroidism and/or cardiac dysfunction ina minimum of 10 patients, 5. Treatment of Thyroid CancerThe physician should have (1) experience a s set forth minimum of for th;! ireatment-of th Go id cancer ina The use of Phosphorus 32 for localization of brain ' tumors, eye tumors, etc., represents specialized applications of radioisotopes requiring considerable refinement in techique s and specialized types o f in st me nba tion, purposes i s normally limited to physicians already having substantial exgerience i n both diagnostic and thera7eutic use of radioisotopes, as well as specific experience i n the modalities being proposed, The use of radiophosphorus for these Applications proposing such use of radioisotopes should be supported within for nation describing the clinical procedures t o be followed and the instrumentation Treatment of Leukemia, Polycythemia and Allied Blood a, The physician should be expert in therapeutic radiology, internal nedicine (or hematology) or pathology. aoard certification will serve a s evidence of qualifications,

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b, Physicians who are not qualified as indicated above should actively g art ici pate in the use of Phosphorus 32 f or t h e treatment of leukemia, polycythemia vera and/or other blood dys cras i as ina minimum of 5patients. 3., Phosphorus 32 - Chromic Phosphate a. Intra cav itv Use in the Palliation of Carcinomatous (1) The physician should actively participate in phosphate inthe treatment of a minimum of (2) Experience in the intra cavity use of colloidal Gold 198 will serve in lieu of the recomenda- -NOTE3 Applications proposing the intra cavity use should be accompanied by a properly annotated drawing of the infusion apparatus t o be used o r a literature reference t o such apparatus, be Interstitial …