Biokinetics Study for Tc-99m MAG3 in Pediatric Molecular Imaging

NCT03107286 | Completed FDA Drug

• 1 other identifier: IRB-P00025086_3
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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 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 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 MAG3, 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.

Conditions

Renal Disease

Outcome Measures

Primary Outcomes (1)

• Radioactivity in target organs at various time points

  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.

  6 hours

Study Arms (1)

Tc-99m MAG3

Children ages 1-6 years old will be eligible to participate. Routine imaging is performed immediately as a dynamic acquisition with 80 frames over 20 min. (15 s per frame). Subjects in each age group will be additionally imaged 2-3 h post-administration. 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.

Drug: Tc-99M-MAG3; Other: Modification in acquisition protocol

Interventions

Tc-99M-MAG3 DRUG

Participants will be asked to be imaged at an additional time point during a nuclear medicine study using Tc-99m MAG3

Tc-99m MAG3

Modification in acquisition protocol OTHER

Participants will be asked to be imaged at an additional time point.

Tc-99m MAG3

Eligibility Criteria

• Age: 9 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients within the specified age ranges scheduled at Boston Children's Hospital for a nuclear medicine study utilizing Tc-99m MAG3 will be eligible to volunteer for inclusion in this study.

You may not qualify if:

• Inability to be imaged at the additional time point without the need for sedation or anesthesia

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Johns Hopkins University: collaborator
• University of Florida: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 28237000 BACKGROUND

• 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.

  PMID: 27909182 BACKGROUND

• Fahey FH, Ziniel SI, Manion D, Baker A, Treves ST. Administered Activities in Pediatric Nuclear Medicine and the Impact of the 2010 North American Consensus Guidelines on General Hospitals in the United States. J Nucl Med. 2016 Sep;57(9):1478-85. doi: 10.2967/jnumed.116.172148. Epub 2016 Apr 7.

  PMID: 27056617 BACKGROUND

• Grant FD, Gelfand MJ, Drubach LA, Treves ST, Fahey FH. Radiation doses for pediatric nuclear medicine studies: comparing the North American consensus guidelines and the pediatric dosage card of the European Association of Nuclear Medicine. Pediatr Radiol. 2015 Apr;45(5):706-13. doi: 10.1007/s00247-014-3211-x. Epub 2014 Nov 1.

  PMID: 25367355 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Frederic H Fahey, DSc

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: January 2, 2018
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)