Cystic FibrosisNCT04451213
Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis
A study testing MRI head in people with Cystic Fibrosis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- MRI head
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2021to 23 Dec 2022
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, aged greater or equal to 30 years
- A diagnosis of CF
- Primary school education or above
- Able to provide informed consent
Who cannot join
- Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)
- Existing neurological disease affecting cognition (including stroke and traumatic brain injury)
- Existing diagnosis of dementia documented in medical notes
- Vascular complications of diabetes
- Requiring supplemental oxygen -long term or overnight
- Hepatic failure
Show all 10Show fewer
- Overt psychiatric disorders
- Past or present alcohol or recreational drug misuse
- Pregnancy
- Current infection Smoker
Trial locations and contacts
1 site in 1 country.
About this study
CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.
Read the detailed description
Patients with CF have several potential risk factors which may predispose them to memory problems. Because the CF population has historically only been young, this is not something that has been focused on. No research has currently identified whether patients with CF have a much earlier risk of developing cognitive impairment or how CF impacts on the brain.
There has not previously been work in this area of CF and the investigators are in a unique position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on patients with CF for the first time.
- Conditions
- Cystic Fibrosis
- Being tested
- MRI head
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI headDiagnostic test
MRI head
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Diagnostic Test: MRI head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective memory scores
Measured: up to one year
Secondary outcomes (1)
MRI head
the investigators will acquire structural and functional MRI data at 3T to explore brain health of CF patients compared to control data. Structural MRI will include T1 and T2 weighted anatomical images for group comparisons of brain morphology (volume, cortical thickness). T1 weighted images will also be used as reference images for all other MRI parameters.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start23 Aug 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451213
- Sponsor's protocol ID
- 19/MAR/7625
- Status last verified
- Aug 2023
- First submitted
- 21 Jan 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04451213
- Acronym / sponsor ID
- 19/MAR/7625
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Cardiff University
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 30 Jun 2020 (actual)
- 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.
CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.
Detailed description
Patients with CF have several potential risk factors which may predispose them to memory problems. Because the CF population has historically only been young, this is not something that has been focused on. No research has currently identified whether patients with CF have a much earlier risk of developing cognitive impairment or how CF impacts on the brain.
There has not previously been work in this area of CF and the investigators are in a unique position with the Cardiff University Brain Research Imaging Centre (CUBRIC) and its expertise to be able to perform Magnetic Resonance Imagining (MRI) scans and neurocognitive testing on patients with CF for the first time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Diagnostic Test: MRI head |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female, aged greater or equal to 30 years
Key exclusion criteria (10 listed)
- Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI headMRI head | Diagnostic test | experimental |
Primary outcome
Objective memory scores
Time frame: up to one year
1 secondary outcome
MRI head
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI head in people with Cystic Fibrosis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 10 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: finished, as of the sponsor's last update on 31 Aug 2023. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective memory scores (time frame: up to one year). 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 31 Aug 2023.