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CFTR Modulator
Lung Perfusion Mapping for Cystic Fibrosis
Phase 4
Waitlist Available
Led By Mark DiFrancesco, 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
Inclusion CF Cohort: diagnosis of CF by positive sweat test and genetic test
Inclusion CF Cohort: Absence of exacerbation defined as O2 saturation level at 90% or greater when laying flat
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months post trikafta initiation for cf group. baseline for cf and control groups.
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will use a new MRI method to measure regional lung perfusion in children with CF and relate it to regional assessments of ventilation and to serum cytokines or proteomic markers of angiogenesis and inflammatory processes.
Who is the study for?
This trial is for children and young adults aged 6-21 with cystic fibrosis (CF) confirmed by tests, who are about to start Trikafta treatment. Healthy individuals of the same age without lung issues can also join as controls. Participants need stable lung function and no recent exacerbations or antibiotic treatments.
What is being tested?
The study tests a new MRI technique that maps blood flow in the lungs without contrast agents, alongside hyperpolarized Xenon to map ventilation. It aims to understand how CF affects lung perfusion and its relationship with ventilation defects over time.
What are the potential side effects?
Since this trial involves non-invasive imaging techniques rather than drugs, side effects may be minimal but could include discomfort from lying still during MRI scans or mild anxiety due to claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cystic fibrosis through a sweat and genetic test.
Select...
My oxygen levels stay above 90% when I'm lying down.
Select...
I am between 6 and 21 years old and healthy.
Select...
My lung function is within 5% of my best result in the past 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months post trikafta initiation for cf group. baseline for cf and control groups.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months post trikafta initiation for cf group. baseline for cf and control groups.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Degree of concordance between ventilation and perfusion defects
Perfusion Defect Percentage (PDP)
Proteome assays as global indicators of inflammatory/angiogenic processes
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Control CohortExperimental Treatment1 Intervention
10 Healthy control study participants matched for age and gender will undergo one MRI imaging study visit. Hyperpolarized Xenon 129 will be administered through inhalation at one MRI imaging study visit.
Group II: CF CohortExperimental Treatment2 Interventions
16 Cystic Fibrosis Patients will undergo MRI imaging before and 6 months after initiation of triple-combination modulator therapy. Initiation of triple -combination modulator therapy will be determined by clinician and family prior to study enrollment. Hyperpolarized Xenon 129 will be administered through inhalation at two MRI imaging study visits.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,577 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
1,159 Patients Enrolled for Cystic Fibrosis
Mark DiFrancesco, PhDPrincipal InvestigatorCCHMC
Jason Woods, PhDStudy ChairCCHMC
8 Previous Clinical Trials
483 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
166 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 6 and 21 years old.I have been diagnosed with cystic fibrosis through a sweat and genetic test.My oxygen levels stay above 90% when I'm lying down.You have not experienced a worsening of your condition and can do a reliable breathing test.I am planning to start Trikafta for my cystic fibrosis.I am between 6 and 21 years old and healthy.Healthy participants should not have any known conditions that affect their lung function, according to the researchers.You have not taken antibiotics for a sudden worsening of your condition for at least 14 days before the MRI visit.My lung function is within 5% of my best result in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: CF Cohort
- Group 2: Control Cohort
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.