Using MRI to Observe Lung Changes in Infants With CF Compared to Infants Without CF
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/27/2016 |
| Start Date: | February 2013 |
| End Date: | July 2017 |
| Contact: | beth Decker, RN |
| Email: | beth.decker@cchmc.org |
| Phone: | 513-803-4325 |
MRI Predictors of Infection, Inflammation, and Structural Lung Damage in CF (Cystic Fibrosis)
Our research is comparing the lungs of babies and young children with CF (cystic fibrosis)
to those without CF. We are looking at the blood flow in the lungs to help doctors better
understand how CF damages lungs and how to prevent this damage in the future. We will use
MRI (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes
in the lungs of babies and young children with CF. We will look at the special blood tests
to see if they can work as signals for the doctors to better understand when changes are
happening in the lungs.
For the babies with CF, we will compare MRI images of the lungs to their CT images (also
sometimes called CAT scans or Computerized Tomography). We hope that this study will help us
reduce the number of X-rays and CT scans children with CF might get in the future. Because
MRI's do not use radiation, this could reduce the amount of radiation exposure that children
with CF would get over their lifetime.
to those without CF. We are looking at the blood flow in the lungs to help doctors better
understand how CF damages lungs and how to prevent this damage in the future. We will use
MRI (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes
in the lungs of babies and young children with CF. We will look at the special blood tests
to see if they can work as signals for the doctors to better understand when changes are
happening in the lungs.
For the babies with CF, we will compare MRI images of the lungs to their CT images (also
sometimes called CAT scans or Computerized Tomography). We hope that this study will help us
reduce the number of X-rays and CT scans children with CF might get in the future. Because
MRI's do not use radiation, this could reduce the amount of radiation exposure that children
with CF would get over their lifetime.
Cystic fibrosis (CF) is a well characterized multi-organ disease producing mucus
obstruction, chronic lung infection, inflammation, and oxidant stress. These processes
result in airway damage, chronic pulmonary symptoms, and ultimately death in young
adulthood. These processes are largely silent in the infant and toddler CF population, and
ultimately result in lung damage and symptoms of CF. Detection and monitoring of lung
disease in infants and toddlers with CF is currently limited, and is a major barrier to
advancements in care and research for this population.
This study will be performed in CF and non-CF controls age 6 months - 4.5 years, with
repeated measures in CF patients over this window. We intend to examine new techniques to
evaluate the lung of CF infants based on magnetic resonance imaging (MRI) that incorporates
measurements of lung structure and blood flow. In the CF group, we will augment MRI images
with CT images to determine structural relationships between MR and CT (a gold standard to
assess lung structure in CF). We will correlate imaging data with core peripheral biomarkers
of CF using an unbiased, metabolomic and proteomic-based approach. It is hoped that the
results of this study will provide support for the use of MRI to monitor lung structure and
blood flow in early CF lung disease, potentially providing a modality to monitor disease
status independent of radiation exposure.
We hypothesize that MRI of the lung and pulmonary circulation has the potential to serve as
a sensitive and portable tool to monitor early CF lung disease. We will examine three
functional aspects of pulmonary blood flow (total and regional pulmonary perfusion, vascular
resistance, and aortopulmonary collateral blood flow) compared with structural assessment of
the lung by MRI and CT.
This proposal couples advancements in magnetic resonance imaging (MRI) techniques with the
emerging technologies of metabolomics and proteomics, linking new MR imaging to candidate
and novel pathway analysis. We will use the new technologies (metabolomics and proteomics -
performed on peripheral blood samples) to determine if altered signaling pathways detected
in the blood are related to changes in the lung. We hypothesize that changes in pulmonary
perfusion and/or structure can be correlated with peripheral biomarkers identified by
metabolomics and proteomic methodology.
Candidate metabolomic pathways that have been shown to segregate CF from non-CF conditions
(including oxidative status, purinergic signaling, and glucose metabolism) will be the focus
of initial biomarker analysis, with advanced bioinformatic techniques applied to define
novel relationships between the metabolome and imaging. Proteomics will serve a validating
function, helping to assign enzyme pathways to metabolomics alterations.
The study design includes 30 CF subjects divided into 2 age groups (6 to 12 month old and 24
to 36 month old) who will receive chest CT and High Resolution CT (HRCT) at baseline and 12
months later. They will be compared to 30 age matched non-CF subjects who will have one
visit of MRI with contrast. The non-CF group only includes subjects scheduled for MRI for
clinical reasons and will have an additional chest imaging at the end of their scheduled
MRI. Both groups will have blood drawn to measure metabolomic and proteomic markers.
obstruction, chronic lung infection, inflammation, and oxidant stress. These processes
result in airway damage, chronic pulmonary symptoms, and ultimately death in young
adulthood. These processes are largely silent in the infant and toddler CF population, and
ultimately result in lung damage and symptoms of CF. Detection and monitoring of lung
disease in infants and toddlers with CF is currently limited, and is a major barrier to
advancements in care and research for this population.
This study will be performed in CF and non-CF controls age 6 months - 4.5 years, with
repeated measures in CF patients over this window. We intend to examine new techniques to
evaluate the lung of CF infants based on magnetic resonance imaging (MRI) that incorporates
measurements of lung structure and blood flow. In the CF group, we will augment MRI images
with CT images to determine structural relationships between MR and CT (a gold standard to
assess lung structure in CF). We will correlate imaging data with core peripheral biomarkers
of CF using an unbiased, metabolomic and proteomic-based approach. It is hoped that the
results of this study will provide support for the use of MRI to monitor lung structure and
blood flow in early CF lung disease, potentially providing a modality to monitor disease
status independent of radiation exposure.
We hypothesize that MRI of the lung and pulmonary circulation has the potential to serve as
a sensitive and portable tool to monitor early CF lung disease. We will examine three
functional aspects of pulmonary blood flow (total and regional pulmonary perfusion, vascular
resistance, and aortopulmonary collateral blood flow) compared with structural assessment of
the lung by MRI and CT.
This proposal couples advancements in magnetic resonance imaging (MRI) techniques with the
emerging technologies of metabolomics and proteomics, linking new MR imaging to candidate
and novel pathway analysis. We will use the new technologies (metabolomics and proteomics -
performed on peripheral blood samples) to determine if altered signaling pathways detected
in the blood are related to changes in the lung. We hypothesize that changes in pulmonary
perfusion and/or structure can be correlated with peripheral biomarkers identified by
metabolomics and proteomic methodology.
Candidate metabolomic pathways that have been shown to segregate CF from non-CF conditions
(including oxidative status, purinergic signaling, and glucose metabolism) will be the focus
of initial biomarker analysis, with advanced bioinformatic techniques applied to define
novel relationships between the metabolome and imaging. Proteomics will serve a validating
function, helping to assign enzyme pathways to metabolomics alterations.
The study design includes 30 CF subjects divided into 2 age groups (6 to 12 month old and 24
to 36 month old) who will receive chest CT and High Resolution CT (HRCT) at baseline and 12
months later. They will be compared to 30 age matched non-CF subjects who will have one
visit of MRI with contrast. The non-CF group only includes subjects scheduled for MRI for
clinical reasons and will have an additional chest imaging at the end of their scheduled
MRI. Both groups will have blood drawn to measure metabolomic and proteomic markers.
Inclusion criteria:
CF
- Age at enrollment 6 to 12 months or 24 to 52 months.
- Diagnosed with two CF-causing mutations ('severe' mutations, classes 1, 2, or 3).
Non-CF
- Age at enrollment 6 months to 52 months
- Clinically scheduled for MRI neuroimaging
- Negative history of renal abnormalities
Exclusion criteria:
CF
- Pulmonary exacerbation
- Any known intracardiac defects
- Serum creatinine > 1.5 times the upper limit of normal for age
- Cystatin C > 0.53 (cutoff for normal range)
Non-CF
- Active lung disease as determined by assessment of anesthesiologist
- Any known intracardiac defects
- Results of the most recent serum creatinine within past 12 months above normal range
for age
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: John P Clancy, MD
Phone: 513-803-7690
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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