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Perflubron as a gastrointestinal MR imaging contrast agent in the pediatric population
G S Bisset1, K H Emery, M P Meza
1Department of Radiology, Duke University Medical Center, Box 3808, Durham, NC 27710, USA.
Insights
Orally administered perflubron improved bowel recognition on MR imaging for most pediatric patients. This gastrointestinal contrast agent demonstrated a good safety profile with minor, infrequent side effects.
Area of Science:
- Radiology
- Pediatric Imaging
- Gastrointestinal Imaging
Background:
- Accurate bowel visualization is crucial for MR imaging in pediatric patients.
- Oral contrast agents can enhance gastrointestinal tract delineation.
Purpose of the Study:
- To assess the safety and efficacy of oral perflubron for improving bowel recognition in pediatric MR imaging.
- To evaluate perflubron's performance across different MR sequences and anatomical regions.
Main Methods:
- A multicenter trial involving 39 pediatric subjects.
- Administration of oral perflubron followed by T1-, proton-density, and T2-weighted MR sequences.
- Comparison of pre- and post-contrast imaging; safety assessment via adverse events, labs, and vital signs.
Main Results:
- Significant improvement in bowel darkening observed in 85-95% of subjects across MR sequences.
- High efficacy rates (71-100%) for abdominal and pelvic regions.
- Improved visualization of pancreas, liver, mesenteric fat, and pathology in at least 75% of subjects.
- 23% experienced minor, digestive-related adverse effects; no significant safety concerns from labs or vital signs.
Conclusions:
- Perflubron is a safe and effective oral contrast agent for pediatric MR imaging.
- It enhances bowel recognition and visualization of abdominal/pelvic structures.
Objective:
To evaluate the safety and efficacy of orally administered perflubron for bowel recognition on MR imaging in a pediatric population.
Materials And Methods:
A multicenter trial evaluated 39 pediatric subjects before and after ingestion of perflubron with T1-, proton-density, and T2-weighted sequences through the abdomen and/or pelvis. Post-contrast images were compared with pre-contrast images. Safety was evaluated through assessment of adverse events, clinical laboratory parameters, and vital signs.
Results:
With regard to efficacy analysis, improvement in the percent of bowel darkened was observed for 85 % of the subjects on T1-weighted images and for 95 % of the subjects on proton-density and T2-weighted images. For images of the abdominal region, the percent of bowel darkened was improved for 90-92 % of the subjects across pulse sequences. Improvement rates for the images of the pelvic region ranged from 71 % to 100 %. For at least 75 % of the subjects, proton-density and T2-weighted images of the body and tail of the pancreas, left lobe of the liver, mesenteric fat, and pathological tissue were improved relative to predosing images. Twenty-three percent of the subjects experienced some adverse effects, most of which were minor and related to the digestive system. Clinical laboratory and vital sign evaluations revealed no trends associated with the administration of perflubron.
Conclusion:
Perflubron is a relatively safe and effective gastrointestinal MR contrast agent in the pediatric population.