Biokinetics Study for Tc-99m MDP in Pediatric Molecular Imaging
NCT ID: NCT03107247
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2017-10-31
2021-10-06
Brief Summary
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* Collect image-based pharmacokinetic (PK) data from patient volunteers in different age groups scheduled for routine nuclear medicine studies for Tc-99m methylene diphosphonate (MDP), 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 Tc-99m MDP, 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.
Detailed Description
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* Collect imaging-based pharmacokinetic (PK) data from patient volunteers in different age groups scheduled for selected, routine nuclear medicine studies for Tc-99m methylene diphosphonate (MDP), 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.
Pediatric absorbed dose estimates that are typically reported apply adult PK data with pediatric variations in body size and anatomy but not for differences in physiology between children and adults. Depending on the diagnostic agent, such differences can be of greater impact than anatomical differences. The investigators will acquire image data that will allow us to develop PK models for Tc-99m MDP, a radiopharmaceutical routinely used in pediatric nuclear medicine fr skeletal imaging. Patients undergoing standard of care imaging will be asked to consent to being imaged at one additional time point, either prior or subsequent to the time typical for clinical imaging. No patient will be asked to undergo more than one additional imaging time-point.
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 an additional time point.
Patients ages 1-16 years old will be included. Routine imaging will be collected 3-4 h post-administration with a dual-detector rotating gamma camera. Half of the subjects will also be imaged between 30 and 90 min, PA. The 2nd half will be at 4-6 h, post-administration.
The additional imaging will occur on the day of the clinically indicated procedure. Other than that, there is no timeline associated with this study.
Image data acquired from the subjects will be analyzed by the principle investigator and by colleagues at Johns Hopkins University and the University of Florida. Regions of interest will be defined around pertinent target organs and tissues and the count data recorded. The specific target organs will depend on the particular radiopharmaceutical. The data for each age range and time point will be pooled, normalized and fit to models describing the pharmacokinetics. The resultant models will be evaluated for age-based variations in the PK data and compared to existing, published models based on adult data to evaluated age based differences. Lastly, the impact that the more accurate PK has on dosimetric estimates of patients of different ages will be analyzed.
The number of subjects required at each time point will be determined using nonlinear mixed effects modeling software to model the data and adjust for covariates. The likelihood ratio test based on the objective function value (OFV) will be used to estimate PK parameters for varying doses and ages using a Bayesian approach. The proposed sample size plan with subjects imaged at different time points is predicated on the Monte Carlo Mapped Power (MCMP) method to achieve 80% power for detecting age and dose effects and robust coverage in estimating individual PK parameters. It is expected that there will be 5-10 subjects per age group depending on the statistical requirements as described above.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Patients receiving Tc-99m MDP studies
All patients within the specified age ranges scheduled at Boston Children's Hospital for a nuclear medicine study utilizing Tc-99m MDP will be eligible to volunteer for inclusion in this study.
Imaging Time
Participants will be asked to be imaged at an additional time point.
Interventions
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Imaging Time
Participants will be asked to be imaged at an additional time point.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
9 Months
16 Years
ALL
No
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Johns Hopkins University
OTHER
University of Florida
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Frederic Fahey
Professor of Radiology
Principal Investigators
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Frederic H Fahey, DSc
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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IRB-P00025086_2
Identifier Type: -
Identifier Source: org_study_id