← Back to Search

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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months post trikafta initiation for cf group. baseline for cf and control groups. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degree of concordance between ventilation and perfusion defects

Perfusion Defect Percentage (PDP)

Proteome assays as global indicators of inflammatory/angiogenic processes

+1 more

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,565 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

Initiation of CFTR Modulator (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04467957 — Phase 4

Cystic Fibrosis Research Study Groups: CF Cohort, Control Cohort

Cystic Fibrosis Clinical Trial 2023: Initiation of CFTR Modulator Highlights & Side Effects. Trial Name: NCT04467957 — Phase 4

Initiation of CFTR Modulator (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04467957 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical investigation accommodating individuals of advanced age?

"The parameters for enrollment in this trial stipulate that the youngest participant must be at least 6 years old and the oldest can only be 21."

Answered by AI

What is the population capacity of this research endeavor?

"Unfortunately, this trial is not presently enrolling candidates. It was first posted on 15 November 2020 and updated lastly on 29 August 2022. However, if you are seeking out other studies for cystic fibrosis there are currently 413 clinical trials open to new patients; additionally, fifteen more medical trails concerning Initiation of CFTR Modulator look forward to accepting participants."

Answered by AI

Is this trial still recruiting participants?

"As per the details on clinicaltrials.gov, this medical study has ceased looking for new recruits; having first been opened in November 2020 and last updated in August 2022. Nonetheless, there are 428 other studies actively recruiting participants at present."

Answered by AI

Can you provide examples of prior research focusing on Initiation of CFTR Modulator?

"Currently, 15 studies are running to investigate the effects of Initiation of CFTR Modulator with none reaching Phase 3. Philadelphia, Pennsylvania is a major hub for this research but there are 21 other sites conducting trials on this medical topic."

Answered by AI

Could you describe the inherent risks of using a CFTR Modulator to initiate treatment?

"The safety of CFTR Modulator was rated a 3 because this Phase 4 trial has been given permission to proceed by the relevant authorities."

Answered by AI

Am I eligible to contribute to the research of this trial?

"This clinical trial seeks 26 participants with cystic fibrosis, who must be between ages 6 and 21. In order to qualify, males or females are eligible so long as they have no conditions that would negatively impact their lung function from the point of view of the researchers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis

2020. "Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04467957.

All > Fibrosis > Cystic Fibrosis