Cystic FibrosisNCT01200888
Controlled Ventilation CT in CF Infants
An observational study of Cystic Fibrosis, run by Stanford University at 1 site in United States.
Trial summary
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements… Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Young children with cystic fibrosis at Packard Children's Hospital.
Who may be able to join
- Infants and young children (age ~ 2/3 months to < 5 years)
- Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
- Informed consent by parent or legal guardian.
- Ability to comply with study visit procedures as judged by the investigator.
Who cannot join
- Acute wheezing and/or respiratory distress at either study visit.
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
- Oxygen saturation < 90% on room air at study visit.
- Any medical condition that in the opinion of the investigator precludes subject participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Air Trapping, A2 & A3
Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 \& Measure A3 (% of segmented total lung)
Measured: Baseline & F/U
Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area %
Quantitative Chest CT airway measurements by CT Post-Processing. AWT/TAD = Airway Wall Thickness/Total Airway Diameter LD/TAD = Lumen Diameter/Total Airway Diameter Wall Area % = Wall Area/Total Airway Area (%)
Measured: Baseline & F/U
Secondary outcomes (3)
FEV 0.5 sec
FEV 0.5sec = % predicted
Measured: Baseline & F/U
FEF 85%
FEF 85% (% predicted)
Measured: Baseline & F/U
FEF25-75%
FEF25-75% (% predicted)
Measured: Baseline & F/U
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start1 Sep 2015
- Primary completion1 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Robinson, Stanford University
- Investigators
- Terry Earl Robinson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200888
- Sponsor's protocol ID
- SU-09092010-6830
- Other IDs
- eProt #17572
- Status last verified
- Apr 2018
- First submitted
- 10 Sep 2010
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
- ClinicalTrials.gov ID
- NCT01200888
- Acronym / sponsor ID
- SU-09092010-6830
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young children with cystic fibrosis at Packard Children's Hospital.
Key inclusion criteria (4 listed)
- Infants and young children (age ~ 2/3 months to < 5 years)
- Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
- Informed consent by parent or legal guardian.
- Ability to comply with study visit procedures as judged by the investigator.
Key exclusion criteria (4 listed)
- Acute wheezing and/or respiratory distress at either study visit.
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
- Oxygen saturation < 90% on room air at study visit.
- Any medical condition that in the opinion of the investigator precludes subject participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Air Trapping, A2 & A3
Time frame: Baseline & F/U
Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 \& Measure A3 (% of segmented total lung)
Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area %
Time frame: Baseline & F/U
Quantitative Chest CT airway measurements by CT Post-Processing. AWT/TAD = Airway Wall Thickness/Total Airway Diameter LD/TAD = Lumen Diameter/Total Airway Diameter Wall Area % = Wall Area/Total Airway Area (%)
3 secondary outcomes
FEV 0.5 sec
Time frame: Baseline & F/U
FEF 85%
Time frame: Baseline & F/U
FEF25-75%
Time frame: Baseline & F/U
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Earl Robinson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Air Trapping, A2 & A3 (time frame: Baseline & F/U). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.