Biokinetics Study for F-18 FDG in Pediatric Molecular Imaging
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|ClinicalTrials.gov Identifier: NCT03107325|
Recruitment Status : Withdrawn (No subjects who met the study criteria agreed to participate in two years prior to the COVID-19 crisis.)
First Posted : April 11, 2017
Last Update Posted : October 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Neoplasm||Other: Modification in acquisition protocol Drug: F-18 Fluorodeoxyglucose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biokinetics Study for F-18 FDG for Dose Reduction in Pediatric Molecular Imaging|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||October 1, 2020|
|Actual Study Completion Date :||October 1, 2020|
Only patients scheduled for a whole body PET scan will be eligible. Subjects of all ages will be imaged after 4 h. The CT image from the routine scan will be used for the 2nd scan to avoid additional CT exposure. It is important to note that the patient volunteers will not receive any additional radiation exposure for inclusion in this study. They are only being ask to allow imaging at one additional time point.
Other: Modification in acquisition protocol
Participants will be asked to be imaged at an additional time point.
Drug: F-18 Fluorodeoxyglucose
Participants will be asked to be imaged at an additional time point during an FDG PET study
- Radioactivity (in mCi) in pertinent target organs at various time points [ Time Frame: 6 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107325
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Frederic H Fahey, DSc||Boston Children's Hospital|