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Biokinetics Study for F-18 FDG in Pediatric Molecular Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (No subjects who met the study criteria agreed to participate in two years prior to the COVID-19 crisis.)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
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Johns Hopkins University
University of Florida
Information provided by (Responsible Party):
Frederic Fahey, Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biokinetics Study for F-18 FDG in Pediatric Molecular Imaging
Official Title  ICMJE Biokinetics Study for F-18 FDG for Dose Reduction in Pediatric Molecular Imaging
Brief 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 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.

Detailed Description

The overall objective of this investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible while maintaining and even improving the diagnostic quality of nuclear medicine images. Current dosimetric estimations in children are based on either animal biokinetic or pharmacokinetic data from adults. This is due to paucity of data that exists specifically for children. This situation will be improved through the following specific aims:

Collect imaging-based pharmacokinetic (PK) data from patient volunteers in different age groups scheduled for selected, routine nuclear medicine studies for The overall objective of this investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible while maintaining and even improving the diagnostic quality of nuclear medicine images. Current dosimetric estimations in children are based on either animal biokinetic or pharmacokinetic data from adults. This is due to paucity of data that exists specifically for children. This situation will be improved through the following specific aims:

  • Collect imaging-based pharmacokinetic (PK) data from patient volunteers in different age groups scheduled for selected, routine nuclear medicine studies 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.

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 F-18 FDG for tumor 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.

Children ages 1 to 16 years old will be eligible for this study. Only patients coming in for whole body scans will be recriuted. Subjects in each group will be imaged after 4 h. The CT image from the routine scan will be used for attenuation of the additional scan to avoid additional CT exposure.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Childhood Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE F-18 FDG
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.
Interventions:
  • Other: Modification in acquisition protocol
  • Drug: F-18 Fluorodeoxyglucose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 4, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
25
Actual Study Completion Date  ICMJE October 1, 2020
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03107325
Other Study ID Numbers  ICMJE IRB-P00025086_4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized patient data, with all protected patient information removed, will be shared with collaborators at Johns Hopkins University and the University of Florida. In particular, anonymized nuclear medicine image data will be shared for analysis.
Responsible Party Frederic Fahey, Boston Children's Hospital
Study Sponsor  ICMJE Boston Children's Hospital
Collaborators  ICMJE
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • Johns Hopkins University
  • University of Florida
Investigators  ICMJE
Principal Investigator: Frederic H Fahey, DSc Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP