Biokinetics Study for F-18 FDG in Pediatric Molecular Imaging

Summary

The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear medicine provides potentially life-saving information regarding physiological processes, and is of particular value in children where the rapid and unequivocal diagnosis of pathological concerns is essential for the health of these patients. The overall objective of this investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible while maintaining excellent diagnostic quality of nuclear medicine images. This is particularly important since children are at increased risk due to the enhanced radiosensitivity of their tissues and the longer time-period over which radiation effects may manifest. Current dosimetric estimations in children are based on either animal biokinetic or pharmacokinetic data from adults due to paucity of data that exists for children. This situation will be improved through the following specific aims: * Collect image-based pharmacokinetic (PK) data from patient volunteers in different age groups scheduled for routine nuclear medicine studies for F-18 fluorodeoxyglucose (FDG), a radiopharmaceutical commonly used in pediatric nuclear medicine * Pool and analyze the data for different age groups for each radiopharmaceuticals and * Generate biokinetic models to be used in subsequent dosimetric models for the optimization of pediatric nuclear medicine procedures. Since inadequate pharmacokinetic data currently exist in these patients, the investigators will use the data acquired in this study to establish PK models applicable to different age categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric nuclear medicine make age-dependent adjustments only for patient size and anatomical differences, while time-dependent kinetics from adult PK models are assumed due to the lack of kinetic data for children. The data obtained from this study will make it possible for the first time to determine how the PK in pediatric patients differs from adults. This will be done for F-18 fluorodeoxyglucose (FDG), a radiopharmaceutical commonly used for pediatric nuclear medicine imaging. The overall hope is that results will allow the molecular imaging community to implement pediatric dose-reduction approaches that substantially improve upon current guidelines pointing to future technological advances that could yield even greater dose-reduction while simultaneously improving diagnostic image quality.

Timeline

Start

2019-02-01

Primary completion

2020-10-01

Completion

2020-10-01

Outcome

Outcome not reported

Stopped: “No subjects who met the study criteria agreed to participate in two years prior to the COVID-19 crisis.”

Publications

• Background Fahey FH, Goodkind AB, Plyku D, Khamwan K, O'Reilly SE, Cao X, Frey EC, Li Y, Bolch WE, Sgouros G, Treves ST. Dose Estimation in Pediatric Nuclear Medicine. Semin Nucl Med. 2017 Mar;47(2):118-125. doi: 10.1053/j.semnuclmed.2016.10.006. Epub 2016 Nov 9.
• Background Treves ST, Gelfand MJ, Fahey FH, Parisi MT. 2016 Update of the North American Consensus Guidelines for Pediatric Administered Radiopharmaceutical Activities. J Nucl Med. 2016 Dec;57(12):15N-18N. No abstract available.
• Background O'Reilly SE, Plyku D, Sgouros G, Fahey FH, Ted Treves S, Frey EC, Bolch WE. A risk index for pediatric patients undergoing diagnostic imaging with (99m)Tc-dimercaptosuccinic acid that accounts for body habitus. Phys Med Biol. 2016 Mar 21;61(6):2319-32. doi: 10.1088/0031-9155/61/6/2319. Epub 2016 Mar 1.
• Background Grant FD, Gelfand MJ, Drubach LA, Treves ST, Fahey FH. Radiation doses for pediatric nuclear medicine studies: comparing the North American consensus guidelines and the pediatric dosage card of the European Association of Nuclear Medicine. Pediatr Radiol. 2015 Apr;45(5):706-13. doi: 10.1007/s00247-014-3211-x. Epub 2014 Nov 1.
• Background Sgouros G, Frey EC, Bolch WE, Wayson MB, Abadia AF, Treves ST. An approach for balancing diagnostic image quality with cancer risk: application to pediatric diagnostic imaging of 99mTc-dimercaptosuccinic acid. J Nucl Med. 2011 Dec;52(12):1923-9. doi: 10.2967/jnumed.111.092221.
• Results Khamwan K, Plyku D, O'Reilly SE, Goodkind A, Cao X, Fahey FH, Treves ST, Bolch WE, Sgouros G. Pharmacokinetic modeling of [(18)F]fluorodeoxyglucose (FDG) for premature infants, and newborns through 5-year-olds. EJNMMI Res. 2016 Dec;6(1):28. doi: 10.1186/s13550-016-0179-6. Epub 2016 Mar 17.

Drugs

Indications