Update of DOD Human Radiation Experiment Events

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bU.S. ARMY MEDICAL DEPARTMENT CENTER AND SCHOOL CLINICAL INVESTIGATION REGULATORY OFFICE FROM: CLINICAL INVESTIGATION REGULATORY OFFICE 1608 STANLEY ROAD, BUILDING 2268 AMEDD CENTER t i SCHOOL FORT SAM HOUSTON, TEXAS 78234-6125

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DEPARTMENT OF THE ARMY FORT SAM HOUSTON, TEXAS 78234-6100 MEMORANDUM FOR Deputy Director, Radiation Experlment8 Command Center, ATTN: COL Claud Bailey, 6801 Telegraph Road, Alexandrle, VA 22310 SUBYECTi Update of Human RadLatLon Experlment Events 1. I revlewed human ionizlng radiation cllnical inveetigation experimente eponeored by t h e U . S . Army from 1 9 4 4 to 1974. My review (encloeed) included a oearch of available records, a search of the Clinical Investigation Regulatory Office (CZRO) research study electronic database referred to as the ClinLcal Inveetigation and Research System (CTRS), and a review of related MEDLINE Clinical InvestLgatlon for pre-197S reeearch studies. Contact the Recorda Repository in Saint Lou18 to obtain these recorda. MEDCOM Preventive Medicine worked diligently to obtain the MEDLSNE citations, abstract e, and manuecrlpts There are no records available in my office or the MEDCEN Departments of 3 , In no Lnstance was there any information indicating thatU.S. Army clinical researchers used ionlzlng radiation in humans f o r anythlng other than acceptable clinical indications, e.g., cancer treatment or diagnoaie. 4 . Contact me a t DSN 4 7 1 - 2 5 1 1 or commercial 210-221-2511 if you have que at i one. Chief, Clinical Investigation

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Update of DOD Human Radiation Experiment Evente RECORDS: None available. L;LBs: No references found. clearance of I-131. J Clin Inveet, 3 4 : 1 0 5 7 - 7 2 , 1955 probably descrlbee t h i a MEDICAL.F=W : The study involved 49 adult e and did not benefit the RECORDS: None available. w t No referoncee Iound. w: Bricker NS, nlad CJ: Renal function and 1-131 clearance in hyparthyroFd1siv and myxedema. J Clin Endo, 14:1539-50, 1954 probably describes this et u dy. -MEW: The study involved 11 adults and did not benefit the -1 No referencee found, MEDLINE: No related citatione located. MEDrCALASSES s m21 ThFs study did not involve ionizing radiation. tW&LNE: No related citation e located. employed only for medical diagnoeis. The ionizing radiation aseociated w i t h thle etudy was CX&: No references found. -: de Lena N, et al: Clinical trials wlth irtteneive chemotherapy and radiotherapy Ln Hodykin's dieease. Nat Cancer I n e t l t Mono, 36:403-20, 1973 may be related to atudy. WCAL BSSESSMW: The ionizing radiatlon associated wlth thie etudy was employed only for medical treatment. u r No references found. employed only for medical diay ~ ~ osle. The ionizing radiation associated with thie etudy wae

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RECORDS: None available. -I No references found. -: No related citations located. lG3QlCAL ASSES.$UE.&T: Thie study probably does not involve ionizing radiation. w: No references found. -: No related citatlons located. W ICAL AS S SSMENT: There was probably no ionizing radiation associated with mt No references found. HEDLINE: Nore lrt ted citations located. WALA mSSMENT: The ionizing radiatFon associated with this study was employed only for medical dlagnosie. -I No references found. HEDLINE: No related citations located. -: No related citations located, aD ICAL .ASSESSMENT: This et u dy did not involve ionizing radiation. No references found. RECORDS: None avallable. HEbLINE: No related citations located, probably employed only for medical di agno e ie. The ionizing radi atl on associated with th le study waa BECORDS: None available. W: No references found. MERLIIJE: N o related citations located, W L WES S ME UI The ion iz ln grad la tion associated w l th th ie etudy was employed only for medical di agno sie.

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WI No references found. cell volume from RISA blood volume. Am J Roent, Rad Ther, Nuc Mad 109:820-2, 1970 deecribes thle study. VHEWZ : The ionizing radiation associated with this otudy wae employed only for medical diagnosis. m: No references found. w: Strader WJ, Nusynowitz ML: The meaning of mottling on t h e colloidal radiogold liver scan. MLlit Med 1 3 8 : 7 2 5 - 7 , 1973 describes this e t u d y . There w e r e 132 llver scone between 1968 and 1969. employed only for medlcal diagnosis. BECORDS: None available. w: No references found. -: Hreshchyshyn MM: Resulte o f the Gynecologic Oncology Group triale on ovarian cancer:’preliminary report. N a t Cancer Instit Mono, 421155-65, 1975 deecribes the results of the “Postoperative treatment of women with resectable ovarian cancer with radfotherapy, Melphalan, or no further treatment“ which coincidee with this study title. m L ASSESSMENT: The lonizing radiation associated with this study w a s employed only for medical treatment. w: No related citations located. WC.l4 ? , ASSESSMENT: The ionizing radiation a ~ soci a ted with thi eet u dy was employed only for medLcaL diagnosis. w: No references found. -: Piver MS, et al: Hydroxyurea and radiation therapy Fn advanced cervical cancer. Am 3 Obstet Gynecol, 120:969-72, 1974 describes a similar WD ICAL As ESSMENTt The ionizing radiation associated with thia study was employed only f o r modtcal treatment. RECORDS: None available. on 23 M a y 70 and terminated on 14 Dec 71. XEQLt&Si%$.&tBU: The study probably d i d not involve ionizing radiation.

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m: No references found. -: No related citations Located. wr,ASSE IS Sm : The ionizing radiation associated with this etudy was employod only €or medical treatment, RECORDS: None available. -ASSESSMENT: The ionizing radiation aesociated with thie etudy wae employed only f o r medical diagnosis. UORDS : None available. MEDLINE: No related citations located. UQICAf.i.SESSMENT: The ionizing radiation aeeociated with th La etudy was employed only for medical diagnosis. MEUJliE: No related citations located. MEDICAL AS= SMENT : The ionizing radiatlon associated with th ie study waei employed only f o r medical treatment. BECORDS: None available. -I No references found. lSUJ&E: No related citations located. employed only for medical diagnoels. EORDS : None available. w: No references found. HEDLLNe: No related citations located. employed only for medical di agno e is. The ionizing radiation associated w i t h thF8 study was -: HOlOye PY, et alt CombLnatlon chemotherapy and radiation therapy for small cell carcinoma. JAMA 237:1221-4, 1977 descrlbee a 8FrnLlar clinical employed only for medical treatment. The LonLzing radiatlon a~6oCLatedw i t h thie etudy was

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WORDS : None available. - 1 No references found. 409, 1976 etates 67Ga is beet available ieotope for ocannlng thie tumor. employed only for medical diagnosis. The ionizing radiation associated w l th this et u dy was RECORPS: None available. -: No related citations located. employod only for meclical di agno sie. No references found. CAT, ASSESS ~ ~ W T IT h e ionizing radiation associated with this et u dy was m: No references found. MEDLINE: No related citations located. employed only for medical di agno sie. The ion iz f ng radiation associated with th ie etudy was -: No related citations located. employed only for- medical diagriosis, The ionizing radi atl on associated with this study wae w: No references found. superior agent skeletal Lmaging: coinparlaon with other technetium complexee. Nuc Med 1 6 : 7 4 4 - 5 5 , 1975 s t a t e s technetium-99m Le best available isotope f o r H.EDICAL &jSESSMENX: The ionizing radiation associated with thie atudy was employed only for medical diagnosis. RECORDS: None available. &EE?iW%iNo related citations located. ME.QKALASSES.St?EM: Human9 may not have been exposed to ionizing radiation in

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lymphomas. Semin Nuc Med 5:103-8, 1975 etates gallium-67 i e best available ieotope for scanning Hodgkin'e disease. employed only for medical diagnosis. from the Intergroup Rhabdomyosarcoma Study. Cancer 51:2356-61, 1983 may be a description of th Le study. employed only f o r medical treatment. RECORDS: None avallable, €UE: No references found. preliminary result9 of a coopetative F n t e r y r o u p study. Cancer 4 0 : 2 8 6 4 - 7 3 , 1 9 7 7 may be a descrlption of this study. employed only f o r medical treatment. The ionfting rrrdiatlon associated with th fe etudy waa RECORDS : None avallable. U: No references found. MU U GALAS SSS MENT : This etudy did not involve lanizing radiation. U: No references found. survey (1970-1978). Clin Nuc Med, 3 : 4 5 6 - 6 0 , 1978 reporte thls imaging employed only for medical dlagnosle. The lonizLng radiation aseociated with t h i s etudy was U: No referencee found. UZDLINE: No related citations located. employed only for medical diagnosis. The ionizing radiation associated with th ie etudy was

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EORDS : None available. M,ERI,,m: Ytreclal DO, Bradfield JS: SemLnoma of the testicle: prophylactic mediastinal irradiation vereus perLaortic and pelvic irradiation alone. Cancer 300:628-33, 1972 describes t h i s study. The study was retrospectlve and involved 80 adult malos treated during 1 9 4 7 to 1971. -ASfOSSBlXL: The ionizing rad la tion associated wFth this study was employed only for medical treatment. mr No references found. employed only for medical treatment. w t No references found. lymphomas. SemLn Nuc Med, 5:103-8, 1975 states g a l l i u m - 6 7 1 s excellent for imaging Hodgkin's die ease, PRDICALAS-NT: The ionizing radiatlon associated wLth th ioe tud y waa employed only for rnedLcal diagnosis. RECORDS: None available.. approved on 2 7 Mar 7 3 and tetminated on 15 Apr 8 0 . WEDLINE;: No related citations located. WCAL qss6SsMENT: The ionizing radiation associated with this etudy was employed only for medical treatment. on 15 Nov 77 and tetmlnated on 5 May 8 0 . m t No related Citations located. employed only for medical treatment. L;rBs: T h e lnvectigator was COL Merrill C. Johneon, MC. The study w d 8 approved on 30 May 9 2 and termlnated on 18 Feh 7 5 . The IND number was 9169. Am J Roerlt, Rad Thet, Nuc Mecl 121:739-47, 1974 and T h r a l l JH, et al:t Abnormal radionuclide patterns adjacent t o focal ekeletal lesions. Radiology, 115:65963, 1975 may report this study. W CAL ASSESS MEN ii The ionizing radiation aesoclated wLth this etudy was employed only for niedical di agno e ie.

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m: No references found, UDLIU : No related citations located, ME DlC W ASSESS m : The ionizing radiatlon associated with thie etudy wae employed only f o r medical treatment. BRCORDS: None available. m: No referencee found. -: Kaplan WD, et al: A comparison of t w o technetlum-99m-labeled desc rl best hle imagfng technique. employed only formed l cal diagnosis. -I No references found. MEDfCAL8SSMENT: The ionizing radlation associated with this etudy was employed only for medical dtagnoeis. W: No references found. m: No related citations located. employed only for medical di agno sie. BECOFDS; None available. -: No references found. -: Chahinian AP, e t (11: small cell anaplastic carcinoma of the lung. The Cancer and leukernLa Group 8 Experience. Bullet Ln du Cancer 69179-82, 1982 XE QX CA LESS MENT : The ionizing radiation associated with this atudy was employed only for medical treatment. WORDS : None available. employed only for medical diagnosis. The ionizing radiation associated with thie etudy wae C.XRS: No references found. &lUXCAL ASSELSMEY2: The ioniziny radiation associated w i t h this etudy was employed only for medical diagnosis.

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Dec 7 3 and terininatecl on 30 Oct 8 2 . PIEDUNE: No related citations located. MEDICAL ASSBSSMGNT: The ionizing radiation associated with th L6 etudy was employed only f o r medical diagnosis. approved on 7 Nov 73 and terminated on 15 Apr 80. UCAL ASSESSMENT : The ionizing radLation associated w employed only for medical treatment, w: The lnvestigator W a f MAJ Richard Llttenberg, MC. approved on 4 Dec 7 3 and tecmlnnted in Jul 7 7 . -: No related citations located. th thie atudy wae The study was employed only f o r medical diagnosis. The ionizlng radiation associated with t h i e etudy was & WORDS : None available. - 8 No references found. VS MENT : The ionizing radiatlon associated wlth this study was employed only for medLca1 diagnosis. w: The investigator wa3 COL John W. White, MC. The study waa approved on 7 May 73 and terminated in 1 9 7 5 . employed only for rnedlcal diagnosis. ENT: The ionlzlng radiation associated with this study waa RECORDS: None available. w: The investigator was COL Martin P. Nusynowitz, MC; The etudy was approved on 4 Dec 7 3 . 9 : 1 5 3 - 7 , 1 9 7 4 may describe this etudy. employed only for medical diagnosis. Blurnhardt R, Nusynowitz M t : A guide to bone scannlng. Am Fern Phys, The ionizing radiation aseociated with thie etudy waa

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BSCORDS: None available. L'L;LBs: The investigator wae MAJ David Milstein, MC. The etudy was approved o n -: No related citations located. employed only for medical diagnosis. W: The inveetlgator wag MAJ David Mils tel n, MC. The et u dy was approved on 15 Nov 73 and termlnated in 1 9 7 5 . LIEDLINE: No related cLtation9 located. -: No related cl tat i one located, HE DIC At NTI The Lonizing radiation associated with thLe etudy wae employed only f o r medlcal dlaynouls. m:No related cltatlons located. MEDICAL ASSESSMENT: The ionizing radiation aseoclated with thie etudy was employed only for medLcaL diagnosis. RECORDS: None avnllable. approved in 1 5 Dec 7 3 . scanning. Surg, Gynecol, Okstet 1 3 7 ~ 4 2 4 - 3 0 , 1 9 7 3 may deecrLbe t h i s study. employed only for mecllcal diagnosis, The ionLzLng radiation associated with thie etudy was BECORDS: None available. SXRS: No references found. MEDLINE: No related citations located. MEDZCAL ASSG$Z%€LU: The FonLzing radLatLon associated with this etudy was employed only for medical diaynosle.

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U: The investigator was HAJ David Mil stein, MC. The etudy wae terminated UD LIN F, : No related citations located. employed only for medCcal dlsgnosle. CAL ASSESSMENT: The Lonlzlng radiatFon as soc late d with th ie study wag on 1 5 Nov 7 3 and terminated on 1 Dec 7 7 . m:No related citations located. employed only for medical dlagnosia. ICAro A SSESSME U : The ionizing radiation a seo cia ted w l th this study was U CORDS I None av allah le. E;LBs: NO references found. Oncol 19:1585-91, 1983 describes t h i s study (CALGB 7 4 1 1 ) . employed only formed l cal treatment. )3EDTCAL ASSESSMENT: This etudy dld not: involve ion l zing radiation. &XQRQs:None av allah le. €,US: No references found. MEDICAL AS S VS WU : The Lonizing radiatLon as soc late d with this etudy was employed only for medical treatment. RECORDS: None available. EULQg: Eyre HJ, et al: Ran clod zed conrparieone of radiotherapy and CCNU ver ~ u er a dio …