ML20059L361
| ML20059L361 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/1994 |
| From: | Alexander Adams Office of Nuclear Reactor Regulation |
| To: | Office of Nuclear Reactor Regulation |
| References | |
| PROJECT-684A NUDOCS 9402040150 | |
| Download: ML20059L361 (51) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION yb WASHINGTON, D.C. 20555-0001
.....f January 24, 1994 Project No. P-684 PARTICIPANT:
Idaho Brain Tumor Center (IBTC)
FACILITY:
U.S. Department of Energy Power Burst Facility
SUBJECT:
SUMMARY
OF MEETING BETWEEN IBTC AND THE NRC STAFF On December 15, 1993, representatives of the NRC staff were briefed on the plans of the IBTC to lease the Power Burst Facility (PBF) from the U.S.
Department of Energy (D0E), have.NRC license the facility as a research reactor for medical therapy, perform modifications to the facility, and use the facility to conduct Boron Neutron Cancer Therapy (BNCT). A list of attendees is provided in Attachment 1.
Briefing material presented by the IBTC is provided in Attachment 2.
Dr. Paul, of the IBTC, presented an overview of BNCT.
Briefly, the patient is given a drug from which boron is preferentially absorbed by the tumor tissue.
A beam of epithermal neutrons causes the boron atom to fission into lithium and an alpha particle.
These high energy particles kill the cancer cells.
Mr. Leatham, of the INEL, presented an overview of the PBF. The INEL is acting as an advisor to the IBTC on reactor technical issues.. The PBF is located at the Idaho National Engineering Laboratory. The facility is currently idle. The facility was used by the AEC/D0E to conduct research into reactor fuel behavior. The facility was operated at power levels up to 28 MW(t) and the facility had pulsing capability.
IBTC is considering operating the reactor at 10 MW(t) without pulsing capability. The reactor fuel is 1
uranium dioxide diluted with calcia stabilized zirconia enriched to 18 percent U-235. Core burnup is approximately 25,000 MW-hours.
The facility operated from 1971 to 1985. The facility has undergone limited maintenance since-e operations ceased.
Reactor fuel has been stored in water with controlled water chemistry.
To use the PBF for BNCT, modifications to the facility would have to be made.
The facility was not designed to extract a beam from the reactor core. The biological shielding needs to be modified and a beam tube, filters, shutters, and a treatment area need to be installed.
The NRC staff discussed.the licensing requirements for research reactors.
Areas such as the safety analysis report, technical specifications, emergency.
planning,. security planning, reactor operator. licensing and requalification, financial assurance and indemnity were discussed. Novel aspects of the project such as the fact that the facility is already in existence and was constructed without a NRC issued construction permit, the need for facility modification, and the licensing of the facility as a medical therapy facility n
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,. January.24, 1994 were also discussed. The need for interaction with the staff of the Office of '
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Nuclear Material. Safety and Safeguards and NRC Region IV concerning medical issues surrounding the project were discussed.
IBTC will submit a letter to NRC when they are prepared to.go-forward.with the NRC licensing process, and an agreement with' DOE for use of the facility is final.
Original signed by:
Alexander Adams, Jr.
Senior Project Manager Non-Power Reactors and Decommissioning Project Directorate Division of Operating Reactor Support Office of Nuclear Reactor Regulation i
Attachments:
As stated DISTRIBUTION:(ZAP. MET] (Adams-lb)
Docket File D.B. Howe PDRs Jim Smith ONDD R/F E. Reis DDRS R/F M. Fleishman T. Murley/F. Miraglia T. Michaels J. Roe M. Mendonca B. Grimes J. Mitchell, ED0 S. Weiss D. Chamberlain, Region IV A. Adams J. Bradfute E. Hylton 0GC E. Jordan ACRS (10) k IFfif[on OhDD J
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. January 24, 1994 t
were also discussed. The need for interaction with the staff of the Office of Nuclear Material Safety and Safeguards and NRC Region IV concerning medical issues surrounding the project were discussed.
IBTC will submit a letter to NRC when they are prepared to go forward with the NRC licensing process, and an agreement with DOE for use of the facility is final.
Alexander Adams, Jr.
,/
Senior Project Manag Non-Power Reactors and Decommissioning Project Directorate Division of Operating Reactor Support Office of Nuclear Reactor Regulation Attachments:
As stated i
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i ATTACHMENT 1 Meeting between IBTC and NRC Staffs NAME ORGANIZATION TELEPHONE Alexander Adams, Jr.
USNRC, Sr. Project Manager (301) 504-1127 Marvin M. Mendonca USNRC, Sr. Project Manager (301) 504-1128 Theodore S. Michaels USNRC, Sr. Project Manager (301) 504-1102 Seymour H. Weiss USNRC, Project Director (301) 504-2170 Morton R. Fleishman USNRC, OCMKR (301) 504-1850 Edwin J. Reis USNRC/0GC (301) 504-1578 John 0. Bradfute USNRC, Project Manager (301) 926-1869 Jan Forsythe EG&G Idaho / Washington, DC (202) 887-5570 Francis F. Paul, MD IBTC (208) 529-7800 Jerald Leathay EG&G Idaho (208) 526-9253 Woody Stroupe EG&G Idaho (208) 526-0185 Jim Smith USNRC, IMNS (301) 504-2613 Donna-Beth Howe, PhD USNRC, IMNS (301) 504-2636
~
/It' 3 Boron Neutron e$,,a<.n w
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Cancer Therapy Overview
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t Presented By:
Francis F. Paul, M.D.
Idaho Brain Tumor Center j
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..hl Revolutionary, Not Evolutionary, improvements Needed in Cancer Treatment Cancer will soon lead all diseases in causing death within U.S.
One-fifth of U.S. population will die of cancer 508,000 deaths / year No significant increase in cancer cure rate since e
early 1970s (about 50% of patients survive 5 years)
Best available treatments ineffective for many forms e
of cancer 5-year survival with.most lethal brain tumors < 3%
5-year survival with metastatic solid tumors < 5%
ALA92001-25
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Initial Tumor Type The most lethal of brain tumors:
Glioblastoma Multiforme ALA93003 '
1
Why Glioblastoma Multiforme
~
for initial BNCT Focus?
Lack of other credible treatment Long-term survival: 0-3%
- Median survival: 4-10 months Ease of selective boron absorption Orphan disease status (minimum delay and cost in FDA approval process)
> 5,000 U.S. fatalities / year.
e Same treatment procedure will apply to all highly-malig)nant brain tumors (~70,000 U.S deaths / year I
ALA87003-21J 1.
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- -- INEL BNCT Program participating organizations ALA87003-49R -
BNCT: One of Very Few Promising Revolutionary Treatments for Brain Tumors
- BNCT: two-step radiation treatment that destroys brain tumors while providing unequalled sparing of organs and other normal tissue l
Step 1: Use of nontoxic, nonradioactive, drug that, l
when administered through bloodstream, concentrates in the tumor, but not in the brain t
Step 2: Activation of boron within head by exposure to external beam of neutrons ALA92001-27A
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BNCT: One of Very Few Promising Revolutionary Treatments for Brain Tumors BNCT causes tumor destruction with brain sparing at cellular level Y-A Neutro B
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Conceptual Design P7-S3A-/- /
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(about 10 minute treatment capability;l ALASSO24-18 en--
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4 Reactor Characteristics Producing an Intense Current of Epithermal Neutrons
= Current increases with
- Reactor power (PBF = 28 MW, other contenders <; 10 MW) j
- Core solid angle view factor
- PBF full core from ~ 2 meters
- BMRR aboutithe same - all others poorer Current decreases with
- Moderator inventory.
PBF metal / water = 2.5
- Typical test /research reactor metal / water = 0.6~
- Reflector quality-
- PBF - poor-(stainless steel)
- Typical test /research reactor - good (beryllium or. carbon)
==
Conclusion:==
PBF will provide > 10 times the epithermal neutron current available from the best alternate source-ALA80038-7 I
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Unique Needs and Capability Provided Only by PBF Adequate epithermal neutron current for
- Heavy filtration of' core gamma rays and non-epithermal neutrons (minimize damrge to normal brain)
- Therapeutic treatment in <; 10 minutes with intact skull and scalp l
- Avoids remote, anesthesia.
- Allows treatment of entire U.S. Glioblastoma Multiforme patient load at a single facility Provides fractionated dose delivery in any ) time span selected by treating physician (;> 10 msec Offers future' prospect for therapeutic dose delivery on-same time scale-ALAS 4035-8 1
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Surgery required Yes No Treatment depth 2"
3%"
% patients treatable 50 All Treatment duration 4-6 hrs 3 mins Number patients / year 70 3000 Cost S70,000
~S30,000 ALA93003-3.
Japanese Clinical Data Survival Mean 5 'r%)
ears 10 years No.
(days)
I
(%)_
Alive BNCT All glioblastomas_ treated 38 613 19 9
8/38 Tumors < 6 cm de'op 12 1320 68 29 6/12 located at vertex 6
2183 83-42 3/8 with.10 cm craniotomy 6
2674 100 60 3/5 Non-BNCT 366
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12 BNCT patients in 1968-1985 group having g
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"'24'.......,,1,0 depth be, tween 1968 and 1985 Q-20 46 cases treated S
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ALA90018-16A Ref: Personal Communication of Dr. H. Hatanaka (Japan)
BNCT Development Sequence i
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Conclusions e Need exists for new cancer treatment 4 e Cure rate no better than 30 years ago e e BNCT - Kills tumor - High probability of success - No clinically detectable, normal-brain injury ALA90011-25H
l l Anticipated BNCT Advantages to Brain-Tumor Patients l Improved cure rate / life extension Reduced trauma No diagnostic surgery; patient suitability by 1 MRI measurement of tumor boron No systemic vascular, liver, kidney, or other organ damage No permanent hair loss ALA92001-29A >< ) J
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Anticipated BNCT Advantages to Brain-Tumor Patients (continued) e Reduced lifestyle interruption No mental degradation No diagnostic surgery No hospitalization; outpatient treatment Single,3-minute treatment rather than five days / week for 6-8 weeks e Reduced cost: S30 to 840,000 vs S50 to S100,000 ALA92001-29D m.. u
-1 Worldwide Research May Someday Expand BNCT to Other Tumors . Pituitary-and hormone-dependeni tumors (Oregon Health Sciences Univ /INEL) Breast cancer Prostate cancer . Melanoma (Japan, Australia, BNL, INEL) e . Breast, liver, and pancreatic cancer (Australia) ALA92001-12A Y
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OFFICC OF THE GOVERNOR STatt C APiTOL BotSE 8372o-1ooo i2ost 334-2100 OECIL D ANDRus November 15, 1993 To Whom it May Concern:
Idaho is home to one of the premier nuclear research facilities in the world:
The U.S. Department of Energy's (US-DOE) Idaho National Engineering L&boratory (INEL).
INEL has been a key player in the research, development, and commercial-ization of many nuclear technologies.
Once again, this facility has the opportunity to expand its capabilities and engage in a humanitarian and profitable effort.
The Idaho Brain Tumor Center (IETC) has plans to utilize the existing DOE rea tor at the Power Burst Facility (PBF) at INEL for radiation therapy to brain tumor patients.
This therapy, known as Boron Neutron Cancer Therapy (BNCT), has been under in the United States and abroad since the 1930s.
In development the US-DOE designated the INEL as the National Center for
- 1992, ENCT Measurement and Development.
One of the integral elements of BNCT is the neutron source. The PBF produces the spectrum and quality of therapeutic neutrons needed f or BNCT. IETC is seeking to lease the PBF reactor from US-DOE and to convert it to a commercial treatment center for brain cancer victims by the year 1996. This would provide BNCT treatment at a of conventional cost to patients substantially less than the cost therapy. By the second year of operat-icn, IBTC hopes to be the world center for BNCT and to be operating with a positive cash flow. Over 5,000 people " die.from Glioblastoma Multiform, a deadly form of brain cancer, in the United States every year. Presently, most victims are treated with surgery and chemotherapy. This treatment can cost up to $100,000 per patient, and then patients BNCT is one of a few can expect to live less than one year. developing technologies which could dramatically extend the life span of brain tumor patients; and it costs up to two-thirds less than conventional treatment. This project coincides with Idaho's goals to support technology transfer and develcpment and to bolster and enhance
[ N N inutrWennnt annernen 9, November' 1 85,- 1 9 9 3 Page 2 our economy. It also concurs with the national agenda of improving medical facilities and decreasing the reliance on foreign suppliers for high technology. I fully support and encourage this project and the attainment of a lease by'IBTC from DOE for the use of the FBF reactor. I look forward to hearing about the progress of this project. With best regards, Si cerely, N e M Cecil D. Andrus i Governor CDA:jce r r i ) i N e 6 F F .- ____________ - ____ ____________._____._________________.____________}}