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Gas

Imaging Biomarkers for Cystic Fibrosis (BEGINNING Trial)

Phase 4
Recruiting
Led By Jason Woods, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically-stable with no respiratory tract infection at the time of enrollment
Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Must not have
Individuals currently on ivacaftor therapy (including Kalydeco, Orkambi, and Symdeko) and with at least one gating mutation. Gating mutations include G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, or G1349D
Acute respiratory symptoms (e.g. wheezing) at the time of the MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will use MRIs to look for effects of a new triple-combination therapy in 6-8 year olds.

Who is the study for?
This trial is for children aged 6-8 with Cystic Fibrosis, who have high sweat chloride levels and two specific CFTR gene mutations. They must be able to undergo MRI scans, be clinically stable without recent respiratory infections or changes in maintenance therapies. Kids on ivacaftor therapy or with certain mutations can't join.
What is being tested?
The study tests the effects of a triple-combination therapy using advanced MRI techniques (UTE and 129Xe) after its expected approval by the FDA. It aims to assess how this treatment impacts lung and abdominal health in young patients.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from staying still during MRIs, reactions to contrast agents if used (like mild pain or cold feeling at injection site), and anxiety related to the imaging procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a lung infection and my condition is stable.
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I have two known mutations in my CFTR gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on ivacaftor therapy and have a specific CF mutation.
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I am experiencing wheezing or similar symptoms currently.
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I have a long-term pancreatic condition not caused by cystic fibrosis.
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I have had symptoms like coughing or wheezing in the last 28 days.
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My liver disease is not caused by cystic fibrosis.
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I have been diagnosed with acute pancreatitis.
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I have a long-term lung condition not caused by cystic fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pancreas volume
Ventilation Defect Percentage change from baseline
Secondary study objectives
Abdominal T1 values
Lung reader score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pre TrikaftaExperimental Treatment1 Intervention
129Xe MRI
Group II: Post TrikaftaExperimental Treatment1 Intervention
129Xe MRI

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,293 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
1,141 Patients Enrolled for Cystic Fibrosis
University of VirginiaOTHER
782 Previous Clinical Trials
1,315,658 Total Patients Enrolled
6 Trials studying Cystic Fibrosis
601 Patients Enrolled for Cystic Fibrosis
University of KansasOTHER
153 Previous Clinical Trials
331,723 Total Patients Enrolled

Media Library

129Xe (Gas) Clinical Trial Eligibility Overview. Trial Name: NCT05517655 — Phase 4
Cystic Fibrosis Research Study Groups: Pre Trikafta, Post Trikafta
Cystic Fibrosis Clinical Trial 2023: 129Xe Highlights & Side Effects. Trial Name: NCT05517655 — Phase 4
129Xe (Gas) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517655 — Phase 4
~27 spots leftby Nov 2028
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