Childhood Neoplasm Clinical Trial
Official title:
Biokinetics Study for F-18 FDG for Dose Reduction in Pediatric Molecular Imaging
Verified date | October 2020 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Months to 16 Years |
Eligibility |
Inclusion Criteria: - All patients within the specified age ranges scheduled at Boston Children's Hospital for a nuclear medicine study utilizing F-18 FDG will be eligible to volunteer for inclusion in this study. It is also essential that inclusion does not compromise the potential of acquiring the clinically indicated image acquisition. Exclusion Criteria: - Inability to be imaged at the additional time point without the need for sedation or anesthesia |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Johns Hopkins University, National Institute for Biomedical Imaging and Bioengineering (NIBIB), University of Florida |
United States,
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. Review. — View Citation
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. — View Citation
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/s — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radioactivity (in mCi) in pertinent target organs at various time points | The target-organ radioactivity measurements will be used to estimate the time-integrated activity in the target organs, hopefully leading to a better estimate of absorbed dose to patients of different ages. | 6 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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