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NCT03107286 · ClinicalTrials.gov registry record
Biokinetics Study for Tc-99m MAG3 in Pediatric Molecular Imaging
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 18
- Enrollment target
NCT03107286: Completed study, sponsored by Boston Children's Hospital.
NCT03107286 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03107286 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
Study 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 Tc-99m mercaptoacetyltriglycine (MAG3), 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 ch
Primary Outcome
The target-organ radioactivity measurements will be used to estimate the time-integrated activity in the target organs, hopefully leading to better estimates of absorbed dose to patients of different ages.
Interventions
- DRUG Tc-99M-MAG3
- OTHER Modification in acquisition protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2021-10-06 |
What the finished NCT03107286 record still lists
NCT03107286 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Tc-99M-MAG3 is the first listed.
NCT03107286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03107286 about?
NCT03107286 is a clinical study titled "Biokinetics Study for Tc-99m MAG3 in Pediatric Molecular Imaging". 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 fo...
What is the current status of trial NCT03107286?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2018-01-02. Estimated completion is 2021-10-06.
What interventions are being tested in trial NCT03107286?
The interventions under investigation include: Tc-99M-MAG3 (DRUG), Modification in acquisition protocol (OTHER).
Who is sponsoring clinical trial NCT03107286?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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