Accurate dosimetry: An essential step towards good clinical practice in nuclear medicine

Nuclear Medicine Communications

Volumn 26, Issue 7, 2005, Pages 581-586

  Bacher, Klaus ^a   Thierens, Hubert M ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

Clinical trial; Good clinical practice; Patient dosimetry; Radionuclide therapy; Radiopharmaceutical development

Indexed keywords

(3 IODOBENZYL)GUANIDINE I 131; 1,4,7,10 TETRAAZACYCLODODECANE 1,4,7,10 TETRAACETIC ACID; 1,4,7,10 TETRAAZACYCLODODECANE 4,7,10 TRICARBOXYMETHYL 1 YLACETYL DEXTRO PHENYLALANINE 3 TYROSINE OCTREOTIDE Y 90; CARBON 14; IODINE 131; NEW DRUG; OCTREOTIDE[3 TYROSINE]; RADIOPHARMACEUTICAL AGENT; TRITIUM; UNCLASSIFIED DRUG; YTTRIUM 90;

ACCURACY; BONE MARROW TOXICITY; CLINICAL TRIAL; CONFERENCE PAPER; DIAGNOSTIC IMAGING; DOSE CALCULATION; DOSIMETRY; DRUG RESEARCH; EUROPEAN UNION; GOOD CLINICAL PRACTICE; HUMAN; IN VIVO STUDY; LAW; MEDICAL ETHICS; METHODOLOGY; NEPHROTOXICITY; NONHUMAN; NUCLEAR MEDICINE; PATIENT MONITORING; PRACTICE GUIDELINE; PREDICTION; PUBLICATION; RADIOTHERAPY; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; STATISTICAL ANALYSIS; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; GUIDELINE ADHERENCE; INTERNATIONALITY; ISOTOPE LABELING; NUCLEAR MEDICINE; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES; QUALITY ASSURANCE, HEALTH CARE; RADIATION DOSAGE; RADIOMETRY; RADIOPHARMACEUTICALS;

EID: 21344462384     PISSN: 01433636     EISSN: 14735628     Source Type: Journal    
DOI: 10.1097/01.mnm.0000169204.13754.e2     Document Type: Article

References (37)

1. World Medical Assembly Declaration of Helsinki. Adopted by the 18th World Medical Assembly, Helsinki 1964 as amended by the 52nd World Medical Assembly, Edinburgh, Scotland, October 2000.
2. Dongen AJ. Good clinical practice, a transparent way of life. A review. Comput Med Imag Group 2001; 25:213-216.
3. Radulovic S, Bosnjak S, Susnjar S. Good clinical practice - important aspects. Arch Oncol 2001; 9(suppl 2):39-40.
4. Meredith R. Clinical trial design and scoring of radionuclide therapy endpoints: normal organ toxicity and tumor response. Cancer Biother Radiopharm 2002; 17:83-99.
5. World Health Organisation. Operational Guidelines for Ethics Committees That Review Biomedical Research. Geneva: WHO; 2000.
6. European Commission. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medical products for human use. Official Journal of the European Communities L-121/34, 1 May 2001.
7. Corrao S, Arnone G, Arnone S, Baldari S. Medical ethics, clinical research, and special aspects in nuclear medicine. Q J Nucl Med 2004; 48:175-180.
8. International Commission on Radiological Protection. Radiological Protection in Biomedical Research. ICRP Publication 62, Annals of the ICRP,(3). Oxford: Pergamon Press; 1991.
9. International Commission on Radiological Protection. Recommendations of the International Commission on Radiological Protection. ICRP Publication 60, Annals of the ICRP,(1-3). Oxford: Pergamon Press; 1991.
10. European Commission. Council Directive 97/43/EURATOM of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/EURATOM. Official Journal of the European Communities L-180/22, 9 July 1997.
11. European Commission - Directorate-General, Environment, Nuclear Safety and Civil Protection. Radiation Protection 99: Guidance on Medical Exposures in Medical and Biomedical Research, 1998.
12. World Health Organisation. Use of Ionising Radiation and Radionuclides on Human Beings for Medical Research, Training and Non-medical Purposes. Technical Report series 611. Geneva: WHO; 1977.
13. International Commission on Radiological Protection. Protection of the Patient in Nuclear Medicine. ICRP Publication 52, Annals of the ICRP,(4). Oxford: Pergamon Press; 1987.
14. International Commission on Radiological Protection. Radiation Dose to Patients From Radiopharmaceuticals. ICRP Publication 53, Annals of the ICRP,(1-4). Oxford: Pergamon Press; 1987.
15. International Commission on Radiological Protection. Radiation Dose to Patients From Radiopharmaceuticals - Addendum to ICRP 53. ICRP Publication 80, Annals of the ICRP,(3). Oxford: Pergamon Press; 1998.
16. Loevinger R, Budinger TF, Watson EE. MIRD Primer for Absorbed Dose Calculations. New York: The Society of Nuclear Medicine; 1991.
17. Stabin MG. MIRDOSE: personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 1996; 37:538-546.
18. Lewi PJ, Marsboom RP. Toxicology Reference Data, Wistar Rat: Body and Organ Weights, Biochemical Determinations, Haematology, and Urinalysis, compiled at Janssen Pharmaceutica. (Janssen Research Foundation Series.). Amsterdam, New York, Holland: Elsevier/North-Holland Biomedical Press; 1981.
19. O’Flaherty EJ. Physiologically based models for bone-seeking elements. Toxicol. Appl Pharmacol 1991; 111:299-312.
20. International Commission on Radiological Protection. Report of the Task Group on Reference Man. ICRP Publication 23. Oxford: Pergamon Press; 1975.
21. Siegel JA, Thomas SR, Stubbs JB, Stabin MG, Hays MT, Koral KF, et al. Techniques for quantitative radiopharmaceutical biodistribution data acquisition and analysis for use in human radiation dose estimates. MIRD Pamphlet No. 16. J Nucl Med 1999; 40:37S-61S.
22. Cristy M, Eckerman KF. Specific Absorbed Fractions of Energy At Various Ages From Internal Photon Sources. ORNL Report ORNL/TM-8381. Oak Ridge, TN: Oak Ridge National Laboratory; 1987.
23. Cloutier RJ, Smith SA, Watson EE, Snyder WS, Warner GG. Dose to the fetus from radionuclides in the bladder. Health Phys 1973; 25:147-161.
24. McDougall IR. Systemic radiation therapy with unsealed radionuclides. Semin Radiat Oncol 2000; 10:94-102.
25. Knox SJ, Meredith RF. Clinical radioimmunotherapy. Semin Radiat Oncol 2000; 10:73.
26. DeNardo GL, Juweid ME, White CA, Wiseman GA, DeNardo SJ. Role of dosimetry in radioimmunotherapy planning and treatment dosing. Critical Rev Oncol Hematol 2001; 39:203-218.
27. 131I using Monte Carlo simulation. J Nucl Med 2002; 43:1101-1109.
28. Thomas SR. Options for radionuclide therapy: from fixed activity to patient-specific treatment planning. Cancer Biother Radiopharm 2002; 17:83-99.
29. DeNardo GL, Hartmann Siantar CL, DeNardo SJ. Radiation dosimetry for radionuclide therapy in a nonmyeloablative strategy. Cancer Biother Radiopharm 2002; 17:107-118.
30. Liu A, Wiliams LE, Wong JYC, Raubitscek AA. Monte Carlo assisted voxel source kernal method (MAVSK) for internal dosimetry. J Nucl Med Biol 1998; 25:423-433.
31. Furhang EE, Chui CS, Sgouros G. A Monte Carlo approach to patient-specific dosimetry. Med Phys 1996; 23:1523.
32. Yoriyaz H, Stabin MG, dos Santos A. Monte Carlo MCNP-4B-based absorbed dose distribution estimates for patient-specific dosimetry. J Nucl Med 2001; 42:662.
33. 131I-MIBG. J Nucl Med 2001; 42:1713-1721.
34. Dorn R, Kopp J, Vogt H, Heidenreich P, Carroll RG, Gulec SA. Dosimetry guided radioactive iodine treatment in patients with metastatic thyroid cancer: largest safe dose using a risk-adapted approach. J Nucl Med 2003; 44:451-456.
35. Siegel JA. The role and options for dosimetry in clinical practice. Cancer Biother Radiopharm 2002; 17:69-70.
36. 90Y-DOTATOC: relevance of kidney volume and dose rate in finding a dose-effect relationship. J Nucl Med 2005; 46:99S-106S.
37. Elliott A. The end of research - or just the end of research as we know it? Nucl Med Commun 2004; 25:329-331.