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Nuclear Physics Enterprises, Cherry Hill, New Jersey
University of Cincinnati, Division of Medical Physics, Cincinnati, Ohio
Radiation Dosimetry Systems of Oak Ridge, Inc., Knoxville, Tennessee
Oak Ridge Institute for Science and Education, Radiation Internal Dose Information Center, Oak Ridge, Tennessee
Veterans Affairs Medical Center 640/151,, Palo Alto, California
Department of Nuclear Medicine, University of Michigan, Ann Arbor, Michigan
Gaithersburg, Maryland
Division of Radiation Research, Department of Radiology, University of Medicine and Dentistry of New Jersey, Newark, New Jersey
Department of Radiology, George Washington University Medical Center, Washington, DC
Pacific Northwest National Laboratory, Richland, Washington
Department of Radiation Research, University of California Davis Medical Center, Sacramento, California
Department of Radiology, Vanderbilt University School of Medicine, Nashville, Tennessee
Correspondence: For correspondence contact: Jeffry A. Siegel, PhD, 216 Society Hill, Cherry Hill, NJ 08003.
ABSTRACT
This report describes recommended techniques for radiopharmaceutical biodistribution data acquisition and analysis in human subjects to estimate radiation absorbed dose using the Medical Internal Radiation Dose (MIRD) schema. The document has been prepared in a format to address two audiences: individuals with a primary interest in designing clinical trials who are not experts in dosimetry and individuals with extensive experience with dosimetry-based protocols and calculational methodology. For the first group, the general concepts involved in biodistribution data acquisition are presented, with guidance provided for the number of measurements (data points) required. For those with expertise in dosimetry, highlighted sections, examples and appendices have been included to provide calculational details, as well as references, for the techniques involved. This document is intended also to serve as a guide for the investigator in choosing the appropriate methodologies when acquiring and preparing product data for review by national regulatory agencies. The emphasis is on planar imaging techniques commonly available in most nuclear medicine departments and laboratories.
The measurement of the biodistribution of radiopharmaceuticals is an important aspect in calculating absorbed dose from internally deposited radionuclides. Three phases are presented: data collection, data analysis and data processing. In the first phase, data collection, the identification of source regions, the determination of their appropriate temporal sampling and the acquisition of data are discussed. In the second phase, quantitative measurement techniques involving imaging by planar scintillation camera, SPECT and PET for the calculation of activity in source regions as a function of time are discussed. In addition, nonimaging measurement techniques, including external radiation monitoring, tissue-sample counting (blood and biopsy) and excreta counting are also considered. The third phase, data processing, involves curve-fitting techniques to integrate the source time-activity curves (determining the area under these curves). For some applications, compartmental modeling procedures may be used. Last, appendices are included that provide a table of symbols and definitions, a checklist for study protocol design, example formats for quantitative imaging protocols, temporal sampling error analysis techniques and selected calculational examples. The utilization of the presented approach should aid in the standardization of protocol design for collecting kinetic data and in the calculation of absorbed dose estimates.
FOOTNOTES
This is the second of a series of MIRD Special Contributions.
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