Patients
Marilyn J. Siegel, M.D.
Mallinckrodt Institute of Radiology
Washington University School of Medicine
St. Louis, MO. USA
FDA Questions: Contrast-enhanced
Pediatric Cardiac CT
• Indications for CT
• Impact of CT on diagnosis & treatment
• Contrast-specific questions:
– Methods of determining dosing
– Limitations of contrast-enhanced CT
– Methods of safety monitoring
• Efficacy data (adults & children)
• Direction of future drug development or utilization
for contrast agents in children
Cardiac CT: Basic Facts
• Need multidetector CT
• Faster imaging times
– fewer motion artifacts
• Higher spatial resolution
– 0.5 to 1.25 mm
– superb 3D images
• Better contrast enhancement
• THE USE OF CT IS INCREASING
Frequency of Contrast Usage
• Contrast mandatory
–100% of cases
• Inherent problems in children
–Small patient size
– Lack of perivisceral fat
• Poor differentiation of soft tissue structures
on non-enhanced CT scans
• Solution: IV contrast
FDA Questions: Contrast-enhanced
Pediatric Cardiac CT
• Indications for CT
• Impact of CT on diagnosis & treatment
• Contrast-specific questions:
– Methods of determining dosing
– Limitations of contrast-enhanced CT
– Methods of safety monitoring
• Efficacy data (adults & children)
• Direction of future drug development or utilization
for contrast agents in children
Indications: Pediatric Cardiac CT
Neonate Adolescent
Pulmonary Sling:
Left pulmonary artery arises from right pulmonary artery
Neonate
Case from J. Schoepf
Aortic Coarctation
10-day old girl with CHF; 8 cc contrast,
3D CT
CT
Patent Ductus Arteriosus
CT MR
Other Indications for
Pediatric Cardiac CT
ASD/VSD
Post ASD repair
Post-operative Evaluation:
• Contrast-related:
–Extravasation at injection site
–Adverse contrast reactions
• Device-related:
–Radiation exposure
Contrast-Related Risks
• LOCM(NICM)
– All 1-3%
– Minor near 1%
– Major (severe) .04% (1:10,000)
– Late 5-8%
• Mortality rate - LOCM since 1980 1:100,000
Adverse Contrast Reactions:
Pediatric Population
• 321 children
• Questionnaire (73% return rate)
• Omnipaque 300/450 (Iohexol)
• Acute reactions 1.9%
– Minor (mild)
– Older patients (> 24 kg)
• Late reactions 6.2%
– Mild or intermediate
– Younger (< 24 kg)
• CT
– 10% of all radiological procedures
– 65% effective dose of all medical x-rays
• Chest X-ray 0.10 mSv
• Pediatric chest CT 1-10 mSv
• Adult chest CT 7-15 mSv
• Cardiac Cath 20-30 mSv
– (3.5 min fluoro/75 sec cine)
Relative Risks
• To individual:
– Lifetime risk of cancer: 20-25% (1 in 4 or 5)
– Added risk: 0.05% (negligible, 1 in 2000)
• To population:
– 600,000 pediatric CT’s in the US / year
– Without CT: 135,000 will die of cancer
– With CT: 135,300 will die of cancer
• Dosing
– IV contrast drawn up by technologist
– Dose verified by radiologist prior to injection
– Contrast administered by radiologist
• Procedural
– Catheter site monitored for extravasation
Mitigating & Preventing
Adverse Contrast Reactions
• Optimize CT settings
–Reduce tube current and voltage
–Increase table speed (mm/sec)
–Limit number of scans
–Use automated dose reduction technology
• Eliminate inappropriate referrals for CT
FDA Questions: Contrast-enhanced
Pediatric Cardiac CT
• Indications for CT
• Impact of CT on diagnosis & treatment
• Contrast-specific questions:
– Methods of determining dosing
– Limitations of contrast-enhanced CT
– Methods of safety monitoring
• Efficacy data (adults & children)
• Direction of future drug development or utilization
for contrast agents in children
Efficacy Data
• 22 pediatric patients
• Confirmatory studies:
– Echocardiography (n=7)
– Angiography (n=7)
– Surgery (n=8)
• Accuracy CT: 96%
– Stenotic vessels: 2 to 5 mm in diameter
200
150
100
Bae 2002
50
0
0 25 50 75 100 125 150 175 200
Time (sec)
200
150
Bae 2002 100
50
0
0 10 20 30 40 50
Time (sec)
• Implication in children
• Use of higher concentration contrast material at
may result in smaller contrast volumes
• Disadvantage
– Viscosity (not usable > 400 mgI/mL)
• Challenge for future research
CT: Future Clinical Utilization