RECRUITING

Regional Monitoring of CF Lung Disease

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.

Official Title

Regional Monitoring of CF Lung Disease After Changes in Mechanical Airway-clearance Treatment

Quick Facts

Study Start:2024-01-05
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06339593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1 Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
  1. 1. Standard MRI exclusions (metal implants, claustrophobia).
  2. 2. For females of childbearing potential: Positive urine pregnancy test or Lactating.
  3. 3. Acute respiratory symptoms (e.g., wheezing) at the time of the MRI
  4. 4. Chronic lung or liver or pancreatic disease not related to CF.
  5. 5. Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Contacts and Locations

Study Contact

Carrie Stevens, BS
CONTACT
(513) 636-9973
carrie.stevens@cchmc.org

Principal Investigator

Jason C Woods, PhD
PRINCIPAL_INVESTIGATOR
Cincinnati Children's Hospital Medica Center

Study Locations (Sites)

Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Jason C Woods, PhD, PRINCIPAL_INVESTIGATOR, Cincinnati Children's Hospital Medica Center

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

Study Start Date2024-01-05
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis