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| FNCA 2009 Workshop on Cyclotron and PET in Medicine |
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Report of
FNCA Cyclotron PET Project Experts Meeting 2009
February 28 - March 2, 2010
Malaysian Nuclear Agency
Background:
The fourth FNCA Workshop on Cyclotron and PET in Medicine named "FNCA Cyclotron PET Project Experts Meeting 2009" was held from February 28 to March 3, 2010, at the Malaysian Nuclear Agency (Nuclear Malaysia), Kuala Lumpur, Malaysia. It was jointly organized by Nuclear Malaysia, Ministry of Science, Technology and Innovation, Malaysia (MOSTI) and Ministry of Education, Culture, Sports, Science & Technology of Japan (MEXT). The workshop was attended by delegates from 7 FNCA countries namely People's Republic of China, Indonesia, Japan, Malaysia, The Philippines, Thailand and Vietnam. The participants of workshop amounted to 20 persons.
Early detection with advanced technology "PET/CT" contributes to human health in Asia. This project is to improve the diagnostic technique for nuclear medicine and radiation safety of Cyclotron and PET facilities in Asian countries. In the workshop, country report on PET/ Cyclotron and clinical studies were presented by each member country and the current status of the project and work plan were discussed.
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| Discussion in the Workshop |
Participants of the Workshop |
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1) On the field of Clinical diagnosis of PETThe following table shows the number of small cyclotron for PET and clinical PET center in the FNCA member countries as of 2010.
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Table 1.
| Country |
Number of small cyclotron for PET |
Number of clinical PET center |
| Australia(*) |
8 |
17 |
| Bangladesh |
0 |
0 |
| China |
70 |
120 |
| Japan |
135 |
260 |
| Korea |
34 |
78 |
| Indonesia |
2 |
2 |
| Malaysia |
3 |
6 |
| Philippines |
1 |
2 |
| Thailand |
2 |
6 |
| Vietnam |
3 |
4 |
| Total |
258 |
495 |
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* Australia did not participate in this PET project.
Focusing the cancer patients, PET studies with PET pharmaceuticals produced and synthesized in small cyclotron facilities are steadily expanding in the FNCA member countries. It is expected Bangladesh, that doesn't implement PET study yet will also start it in the near future. Production and synthesis of 18F-FDG, whose half-life period is about 2 hours, are conducted in the each country's facility now and synthesized 18F-FDG is delivered to nearby clinical PET centers without small cyclotron facility to support their PET study.
Almost all member countries use PET/CT machine, that is combined PET with CT, for the diagnosis of several cancers, namely lung cancer, colon cancer, head & neck cancer, breast cancer, malignant lymphoma and so on. Besides, positive discussion on the diagnosis of Parkinson's disease using new PET pharmaceutical "18F-lDOPA" represents the clinical utilization of PET/CT would be expanded to the other diseases from now.
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Table 2. Number of Case study submitted from each country for ATLAS
| Country |
Number of Case study submitted for ATLAS |
| Australia(*) |
- |
| Bangladesh |
0 |
| China |
30 |
| Japan |
25 |
| Korea |
0 |
| Indonesia |
0 |
| Malaysia |
23 |
| Philippines |
9 |
| Thailand |
17 |
| Vietnam |
0 |
| Total |
104 |
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One hundred four case study data of 18F-FDG were collected for clinical ATLAS from Malaysia, China, Thailand, Philippines and Japan by 2009.
Following topic was introduced to be considered;
- Tumor of less than 1cm in diameter might show negative in 18F-FDG study. On the other
hand, some kind of inflammation like tuberculosis might show positive in 18F-FDG study.
2) On the field of PET pharmaceuticals production
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The value and the facts of the FNCA guideline on the PET pharmaceutical production that was almost finalized in the former PET workshop, were discussed confirming the following items;
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Since the way of the PET pharmaceutical production actually depends on the synthesizing machine used in each facilities, it is not realistic that we organize the unified guideline and recommend FNCA member countries to comply strictly with it. |
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Understanding mutually through our rather serious discussion in the former workshop, we managed to attain the settlement on Quality Control of PET pharmaceuticals that was designed to be accepted by every facility in the FNCA member countries. Regarding the criteria and the repetition of QC test, we distinguished GMP facility from non-GMP facility in this guideline. In addition, considering the difference between average weight of Westerner and Asian, we adjusted some criterion value on it. |
Regarding the radiation exposure through the PET pharmaceutical production, following items was reported;
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We can classify the jobs of FDG production according to the risk of radiation exposure. Comparatively FDG-synthesizing job has small risk because the synthesizing machines do it automatically for the worker. On the other hand, several manual jobs like QC test, Filter membrane integrity test, Exchange of the target material of Cyclotron and so on, have rather high risk of terrible radiation exposure. |
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Filter membrane integrity test is exactly caught in a dilemma which we should give the highest priority to reduction of the worker's radiation exposure or GMP requirement on the pharmaceuticals. This is the most controversial issue for us. From the point of view of producing the pharmaceuticals, this test is actually essential. However, it means to impose terrible radiation exposure on the worker every time. Some case example was introduced that the authorities related to the production of pharmaceuticals allowed the cyclotron facility to conduct the test on the next day after the radioactivity of the material decayed as a result of a negotiation. However, considering the produced FDG is supposed to be injected to the patients on the day, the test on the next day might not be useful from the point of view of preventive measures. |
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Therefore, it is desirable that automated testing devices for several QC test would be adopted in the Cyclotron facility in order to entertain GMP requirements and also prevent the worker from high radiation exposure in the future. |
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Explanation about Surveillance
on personal exposure dose in
PET/CT and Cyclotron facilities
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Presentation on the risk of radiation exposure
through the FDG production
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3) Regarding the surveillance on personal exposure dose in the PET/Cyclotron
facilities using Glass badge
This surveillance is going to be conducted at Putrajaya Hospital and Wijaya International Medical Centre on June 2010, wearing the Glass badge and putting it on the measuring point of the work place for a month. In order to assess the exact exposure of some jobs, it was suggested that the worker put on an additional Glass badge when he/she engages in the high risk job like Filter membrane integrity test, Exchange of the target material of Cyclotron. And this idea was adopted.
4) Future PlanParticipants of the meeting have agreed on the following:
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To continue with the FNCA project, especially in collecting data for ATLAS, until October 2010, at least 10 cases per member country |
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To recommend the following proposals; |
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To include preparing the guideline for radiation safety aspect in cyclotron and PET radiopharmaceutical production, which includes pre-installation and acceptance criteria for Cyclotron; |
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To carry out surveillance on personal exposure dose in PET/CT and Cyclotron facilities for optimization - until 2010; |
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To complete ATLAS beyond cancer - 2011; and |
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The need to study the existing FNCA protocols against the IAEA Technical Document etc., as well as looking into individual modules. |
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| iii. |
A general guideline on pharmaceuticals is already developed by the group. It is rather difficult to develop a single guideline for everybody, and for that reason it is up to the country to develop a specific protocol for each module; |
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To improve FNCA guideline for QA and QC for PET CT by reviewing the new IAEA Technical Document for content and suitability; |
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The progress on pilot study on the use of glass dosimeter for personnel and environmental monitoring for PET/CT and Cyclotron facilities will be presented in the next workshop. |
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| Appearance of PET/CT |
Participants of the meeting visiting
the PET/Cyclotron center
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Participants of the meeting visited Putrajaya Hospital and Wijaya International Medical Centre and viewed the PET/Cyclotron facilities.
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Program of
FNCA Meeting on Cyclotron and PET in Medicine
February 28 - March 2, 2010
Kuala Lumpur, Malaysia
28 Feb 2010, Sunday
| 08:15 |
Depart from Hotel to Malaysian Nuclear Agency |
| 08:45 |
Arrival at Malaysian Nuclear Agency |
| 09:00 |
Welcoming Remarks by Dr. Muhd Noor Muhd Yunus, Deputy Director General (Technical), Malaysian Nuclear Agency And Malaysian FNCA Coordinator
Remarks by Head of the Japanese Delegation, Prof. Keigo ENDO
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| 09:30 |
SessionI: Discussion on current projects
(Chairman : Dato' Dr. Rehir)
i. Work Progress
ii. Past Project Review
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| 10:30 |
Refreshment |
| 10:45 |
SessionII: Discussion on current projects (continued)
(Chairman: Prof. Chen Shengzu)
i. ATLAS
ii. Utilisation of protocols and output for past 3 years
iii. Case study/input - members of the meeting may present any case
studies on the utilization of protocols and output
(duration: 10 mins each)
- China
- Indonesia
- Japan
- Malaysia
- Philippines
- Thailand
- Vietnam
iv. Preparation of Report on progress of current projects and utilization of
protocols
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| 12:45 |
Lunch |
| 14:00 |
Session III: Current Project Activities
(Chairman: Dr. Gerard Goco)
i. Work plan and status
ii. Project activity until end of 2010
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| 16:00 |
Refreshment |
| 16:15 |
Session IV: New Project Cycle
(Chairman: Dr. Muhd Noor Muhd Yunus)
i. Preparation and work plan for new projects after 2010
ii. New sponsors and new leader
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| 17:30 |
Meeting adjourned |
1 March 2010, Monday
| 09:00 |
Depart from Hotel to Putrajaya Hospital |
| 09:45 |
Arrival at Putrajaya Hospital |
| 10:00 |
Visit to Cyclotron Facility at Putrajaya Hospital |
| 12:00 |
Lunch |
| 13:30 |
Depart from Putrajaya Hospital to Wijaya Hospital, Petaling Jaya |
| 14:30 |
Arrival at Wijaya Hospital |
| 16:30 |
Travel to Hotel |
2 March 2010, Monday
| 08:15 |
Depart from Hotel to Malaysian Nuclear Agency |
| 08:45 |
Arrival at Malaysian Nuclear Agency |
| 09:00 |
Confirmation of the Report
(Chairman: Dr. Muhd Noor Muhd Yunus)
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| 10:30 |
Refreshment |
| 10:45 |
Confirmation of the minutes
(Chairman: Dr. Muhd Noor Muhd Yunus)
Closing by Dr. Muhd Noor Muhd Yunus, Deputy Director General (Technical), Malaysian Nuclear Agency And Malaysian FNCA Coordinator
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List of Participants
FNCA Meeting on Cyclotron and PET in Medicine
February 28 - March 2, 2010
Kuala Lumpur, Malaysia
FOREIGN PARTICIPANTS
INDONESIA
DR. KARDINAH
Head of Department Diagnostic Radiology, National Cancer Center,
Dharmais Cancer Hospital
DR. ABDUL MUTALIB
Director, Center for Radioisotopes and Radiopharmaceuricals,
National Nuclear Energy Agency
VIETNAM
MAI TRONG KHOA
Vice Director - Bach Mai Hospital, Hanoi Vietnam
Director - Nuclear Medicine and Oncology Center, Bach Mai Hospital, Hanoi-Vietnam,
Head of Nuclear Medicine Department, Hanoi Medical University
CHINA
PROF. CHEN SHENGZU
Professor,
Cancer Hospital of Chinese Academy of Medical Sciences
PROF. DANG YAPING
Professor,
First Affiliated Hospital of the Xi'an Jiaotong University
THAILAND
ASSOC. PROF. RUJAPORN CHANACHAI
Head of Division of Nuclear Medicine,
Siriraj Hospital, Mahidol University
JAPAN
PROF. KEIGO ENDO
Chairman and Professor,
Gunma Graduate School of Medicine, Diagnostic Radiology and Nuclear Medicine
DR. KAZUTOSHI SUZUKI
Senior Researcher,
National Institute of Radiological Sciences
PROF. MAKOTO HOSONO
Professor,
Kinki University School of Medicine
MR. YOSHIHITO KAMEDA
Deputy General Manager,
Sumitomo Heavy Industries, Ltd.
MR. TAKEHIKO KATO
Project Manager, International Affairs and Research Department
NUCLEAR SAFETY RESEARCH ASSOCIATION (NSRA)
Ms. AI YAMADA
International Affairs and Research Department
NUCLEAR SAFETY RESEARCH ASSOCIATION (NSRA)
PHILIPPINES
DR. GERARD FABIAN DE LEON GOCO
St. Luke's Medical Center,
Nuclear Medicine Dept.
LOCAL PARTICIPANTS
MOHD AMINUDDIN SAID
Jabatan Perubatan Nuklear, Hospital Putrajaya
AHMAD RIZAL YUSOF
Wijaya International Medical Centre
DATO' DR. REHIR DAHALAN
Director, Medical Technology Division
Malaysian Nuclear Agency
DR. MUHD NOOR MUHD YUNUS
Deputy Director General and FNCA Coordinator
Malaysian Nuclear Agency
DR. NORIAH JAMAL
Senior Research Officer, Medical Technology Division
Malaysian Nuclear Agency
RAJA JAMAL BIN RAJA HEDAR (Secretariat)
Research Officer, Planning & International Relations Division
Malaysian Nuclear Agency
SITI SYARINA MAT SALI (Secretariat)
Research Officer, Planning & International Relations Division
Malaysian Nuclear Agency
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