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BEGIN Novel ImagiNG Biomarkers

NCT05517655 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-11-21

No results posted yet for this study

Summary

To determine the treatment effect of triple-combination therapy in 6-8 year olds after presumed FDA approval, using rapid structural and functional pulmonary and abdominal MRI (UTE and 129Xe).

Conditions

Interventions

DRUG

129Xe

Rapid spatial mapping of lung, liver, and pancreatic structure and function is now possible with a combination of hyperpolarized 129Xe and traditional proton MRI, all absent sedation and ionizing radiation.

Sponsors & Collaborators

  • University of Kansas

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jason Woods, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2028-11-01
Completion
2028-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517655 on ClinicalTrials.gov