RECRUITING
I'm interested ...!!
Hyperpolarized MRI of Lung Transplants
Chronic complications such as chronic lung allograft dysfunction (CLAD) remain the leading cause of death and the primary limitation to long-term survival for lung transplant recipients. CT is currently use for longitudinal assessment in the pediatric population with lung transplant. However, it uses radiation that has been related to increase cancer risk. MRI has played a limited role in the evaluation of lung pathologies. To overcome these limitations, the use of inhaled, hyperpolarized (HP) noble gases such as helium-3 (3He) and xenon-129 (129Xe) has come into play. Filling the air spaces within the lungs with either of these HP gases provides enough signal and contrast to obtain quality images on MRI. The primary objective of this study is to evaluate the diagnostic performance of hyperpolarized xenon MRI for the assessment of CLAD in pediatric patients with lung transplant.
Conditions:
🦠 Lung Transplant Rejection
🗓️ Study Start (Actual) 1 July 2021
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Males or females age 8 - 20 years of age at enrollment
    • * Subjects with history of lung transplant
    • * Available clinically indicated pulmonary function test

    Exclusion Criteria:

    • * Any contraindication to the safe performance of MRI (metallic foreign bodies, non-safety rated implanted devices including but not limited to vascular clips, pacemaker, stent, infusion pump, neuro-stimulator, prosthesis)
    • * Subject unable to perform a spirometry
    • * Individuals requiring conscious sedation or anesthesia
    • * Severe claustrophobia
    • * Pregnant females
Ages Eligible for Study: 8 Years to 20 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 February 2021
  • First Submitted that Met QC Criteria 25 June 2021
  • First Posted 28 June 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 July 2023
  • Last Update Posted 11 July 2023
  • Last Verified July 2023
I'm interested ...!!