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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Recruitment Status : Withdrawn (No subjects who met the study criteria agreed to participate in two years prior to the COVID-19 crisis.)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

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.


Condition or disease Intervention/treatment Phase
Childhood Neoplasm Other: Modification in acquisition protocol Drug: F-18 Fluorodeoxyglucose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Johns Hopkins University
University of Florida
Investigators
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Principal Investigator: Frederic H Fahey, DSc Boston Children's Hospital
Publications of Results:
Other Publications:
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Responsible Party: Frederic Fahey, Professor of Radiology, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03107325    
Other Study ID Numbers: IRB-P00025086_4
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Additional relevant MeSH terms:
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Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action