Using MRI to Observe Lung Changes in Infants With CF Compared to Infants Without CF

NCT01832519 | Completed

• 3 other identifiers: CIN001InfantMRIR457-CR11_01R01HL116226
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; CF; MRI; vascularization; perfusion

Outcome Measures

Primary Outcomes (1)

• Pulmonary blood flow

  Comparison of pulmonary blood flow will be done between MRI pair matched subjects.

  CF: Baseline and 1 year; Control: Baseline

Secondary Outcomes (1)

• comparison of lung structure by MRI and CT

  Baseline and one year

Study Arms (2)

CF group

Infants with Cystic Fibrosis will receive 2 chest MRIs with contrast, 2 HRCTs and blood for proteomics and metabolomics at 12 month interval.

Non-CF Control

1 chest MRI with contrast and blood for proteomics and metabolomics

Eligibility Criteria

• Age: 6 Months - 52 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

CF infants 6 to 12 months or CF infants 24 to 36 months or non-CF controls between 6 months to 52 months scheduled for clinical MRI and willing to have contrast.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Roach DJ, Cremillieux Y, Fleck RJ, Brody AS, Serai SD, Szczesniak RD, Kerlakian S, Clancy JP, Woods JC. Ultrashort Echo-Time Magnetic Resonance Imaging Is a Sensitive Method for the Evaluation of Early Cystic Fibrosis Lung Disease. Ann Am Thorac Soc. 2016 Nov;13(11):1923-1931. doi: 10.1513/AnnalsATS.201603-203OC.

  PMID: 27551814 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Cystic Fibrosis; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John P Clancy, MD

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: February 1, 2013
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

US (1)