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Completed No phase listed Observational

Biokinetics Study of Tc-99m DMSA in Pediatric Molecular Imaging

ClinicalTrials.gov ID: NCT03107195

Public ClinicalTrials.gov record NCT03107195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Biokinetics Study of Tc-99m DMSA for Dose Reduction in Pediatric Molecular Imaging

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 4 radiopharmaceuticals 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 Tc-99m dimethylsuccinic acid (DMSA), 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.

Study identification

NCT ID
NCT03107195
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Boston Children's Hospital
Other
Enrollment
24 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
9 Months to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2017
Primary completion
Oct 5, 2021
Completion
Oct 5, 2021
Last update posted
Dec 11, 2022

2017 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Boston Children's Hospital Boston Massachusetts 02115

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03107195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 11, 2022 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03107195 live on ClinicalTrials.gov.

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