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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
BEGINNING Trial 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.Check my eligibility
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.See study design
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.
BEGINNING Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a lung infection and my condition is stable.
Select...
I have two known mutations in my CFTR gene.
BEGINNING Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pancreas volume
Ventilation Defect Percentage change from baseline
Secondary outcome measures
Abdominal T1 values
Lung reader score
BEGINNING 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
815 Previous Clinical Trials
6,531,547 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
1,141 Patients Enrolled for Cystic Fibrosis
University of VirginiaOTHER
754 Previous Clinical Trials
1,245,029 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
341 Patients Enrolled for Cystic Fibrosis
University of KansasOTHER
147 Previous Clinical Trials
325,817 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing wheezing or similar symptoms currently.My doctor plans to treat me with a three-drug combination.I have been diagnosed with cystic fibrosis based on symptoms and tests.I do not have a lung infection and my condition is stable.I am between 6 and 8 years old, or will be 6 within the next 60 days.I have a long-term pancreatic condition not caused by cystic fibrosis.I have had symptoms like coughing or wheezing in the last 28 days.I am on ivacaftor therapy and have a specific CF mutation.I have two known mutations in my CFTR gene.My regular medications have not changed in the last 28 days.My liver disease is not caused by cystic fibrosis.I have been diagnosed with acute pancreatitis.Your sweat chloride level is 60 mEq/liter or higher when tested with a special method using pilocarpine.I have a long-term lung condition not caused by cystic fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Pre Trikafta
- Group 2: Post Trikafta
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is 129Xe impacting the wellbeing of individuals?
"There is substantial clinical evidence that 129Xe treatment is safe, leading our team to assign a score of 3."
Answered by AI
Is enrollment in this experiment still an option for interested participants?
"According to clinicaltrials.gov, this study is presently recruiting participants - the initial posting date was May 1st 2022 and it has since been revised on August 24th of the same year."
Answered by AI
Am I eligible to join this experiment?
"This clinical investigation is seeking 44 participants with cystic fibrosis aged 6 to 8. Essential eligibility criteria includes: the ability to comply with visit and protocol schedules, sweat chloride levels of 60 mEq/liter or more, two well-documented CFTR gene mutations, written consent from subjects (and assent if applicable), no change in maintenance therapies within 28 days prior to enrollment, willingness to undergo MRI scans and a physician's intent to administer triple combination therapy."
Answered by AI
What is the limit to how many participants are accepted into this experiment?
"Affirmative. Per clinicaltrials.gov, this medical research project is actively recruiting participants since its initial posting on May 1st 2022 and most recently updated August 24th 2022. 44 individuals need to be enrolled from a single location."
Answered by AI
Is this research trial open to individuals aged 75 or older?
"According to the study's prerequisites, participants must be between 6 and 8 years old."
Answered by AI
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