Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05699148
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-26
First Post:
2023-01-10
Brief Title:
Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior an Evaluation of Triple Combination Therapy in Children Aged 6 to 11 Years
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFT-CFJunior
Brief Summary:
Recently trial data has shown that the medicine KaftrioTM Elexacaftor Tezacaftor Ivacaftor improves lung function in children aged 6 to 11 years who have cystic fibrosis CF This has led to it being licensed for use in the UK in 2022 and is now being prescribed in this age group There is little information in trials however that shows the effect KaftrioTM ETI has on the gut or liver in this age group
Previous studies in the GIFT-CF series NCT 03566550 NCT04006873 and NCT04618185 has found differences in the functioning of the gut between adults with CF and healthy controls but it is not known whether these differences are present in those aged 6 to 11 years
This study is a significant amendment of the GIFT-CF3 protocol NCT04618185 that aims to measure gut function using magnetic resonance imaging MRI in children with CF before and after starting ETI This study also aims to opportunistically measure lung function and structure using MRI and explore how the liver can be measured using MRI in this age group
The study is split into 2 stages The first is a pilot stage using the modified GIFT-CF protocol recruiting 3 children with CF before starting ETI and 3 healthy volunteers This is to determine we are able to successfully perform these scans in these age groups If successful the second stage will recruit a further 12 children with CF before they start ETI This will take our cohort up to 15 children with CF This cohort will then be rescanned 6 months after starting ETI using the same scan protocol
Previous studies in the GIFT-CF series NCT 03566550 NCT04006873 and NCT04618185 has found differences in the functioning of the gut between adults with CF and healthy controls but it is not known whether these differences are present in those aged 6 to 11 years
This study is a significant amendment of the GIFT-CF3 protocol NCT04618185 that aims to measure gut function using magnetic resonance imaging MRI in children with CF before and after starting ETI This study also aims to opportunistically measure lung function and structure using MRI and explore how the liver can be measured using MRI in this age group
The study is split into 2 stages The first is a pilot stage using the modified GIFT-CF protocol recruiting 3 children with CF before starting ETI and 3 healthy volunteers This is to determine we are able to successfully perform these scans in these age groups If successful the second stage will recruit a further 12 children with CF before they start ETI This will take our cohort up to 15 children with CF This cohort will then be rescanned 6 months after starting ETI using the same scan protocol
Detailed Description:
This is an observational cohort study using MRI to measure gastrointestinal GI function lung structure and function and liver endpoints in children with CF aged 6 to 11 years The study will use a modified version of the protocol used in the GIFT-CF3 study NCT04618185 to measure GI physiology in addition to MRI measures of lung and liver structure and function The aim is to identify whether these measures are changed before and after starting ETI
For the CF participants to be enrolled in the study they must be homozygous or have at least 1 copy of the Phe508del mutation which would mean they are eligible for ETI treatment
The modified MRI protocol taken from NCT04618185 has been shortened to include scans that are taken over three timepoints These timepoints are determined around the ingestion of a test meal which has been previously described Participants will arrive fasted before having a baseline scan After their first scan they will eat their first standardised high fat meal followed by a second standardised high fat meal around 240 minutes after
MRI scans to assess GI function will be taken at baseline fasted 240 minutes post ingestion of a breakfast meal T240 and 300 minutes post breakfast T300 Liver scans will also be taken at baseline and lung scans taken opportunistically at the T240 timepoint In total participants will be asked to remain in the MRI scanner for approximately 30 minutes at a time For comfort participants will be able to watch multimedia programmes through the use of a specially adapted television while in the scanner
Participants will also be asked to complete validated gastrointestinal questionnaires throughout the study day and recall their GI symptoms over the previous 2 weeks and complete a 3 day food diary
The study will be split into two phases The first will be a pilot phase where 3 children with CF aged 6 to 11 years and 3 healthy age and gender matched controls undergo MRI scanning These scans will be assessed to determine whether the scan protocol can be completed by the participants and assess the quality of the images obtained If successful the trial will progress onto the main phase
In the main phase the 12 additional children with CF will be recruited and undergo the above scanning protocol prior to starting ETI We will then ask participants to return for a repeat scans approximately 6 months after starting ETI
For the CF participants to be enrolled in the study they must be homozygous or have at least 1 copy of the Phe508del mutation which would mean they are eligible for ETI treatment
The modified MRI protocol taken from NCT04618185 has been shortened to include scans that are taken over three timepoints These timepoints are determined around the ingestion of a test meal which has been previously described Participants will arrive fasted before having a baseline scan After their first scan they will eat their first standardised high fat meal followed by a second standardised high fat meal around 240 minutes after
MRI scans to assess GI function will be taken at baseline fasted 240 minutes post ingestion of a breakfast meal T240 and 300 minutes post breakfast T300 Liver scans will also be taken at baseline and lung scans taken opportunistically at the T240 timepoint In total participants will be asked to remain in the MRI scanner for approximately 30 minutes at a time For comfort participants will be able to watch multimedia programmes through the use of a specially adapted television while in the scanner
Participants will also be asked to complete validated gastrointestinal questionnaires throughout the study day and recall their GI symptoms over the previous 2 weeks and complete a 3 day food diary
The study will be split into two phases The first will be a pilot phase where 3 children with CF aged 6 to 11 years and 3 healthy age and gender matched controls undergo MRI scanning These scans will be assessed to determine whether the scan protocol can be completed by the participants and assess the quality of the images obtained If successful the trial will progress onto the main phase
In the main phase the 12 additional children with CF will be recruited and undergo the above scanning protocol prior to starting ETI We will then ask participants to return for a repeat scans approximately 6 months after starting ETI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None