Ultrasound in medicine & biology · 2026
Pilot study of a low-attenuation anechoic gastrointestinal contrast filling agent for enhancing transabdominal ultrasound examination of the pancreas.
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Zhang Di, Wang Guan-Yu, Li Chang-Tian, Qu Tai-Mei, Bai Xue-Ting, Zhao Yi, Gao Han-Jing, Xu Shi-En, Zhang Yan, Zhu Cheng-Gang, Wang Yue-Xiang, Lu Yuan-Yuan
Аннотация
BACKGROUND: Transabdominal ultrasound is constrained by gastric gas and collapsed folds when evaluating the pancreas. This study developed a low-attenuation anechoic gastrointestinal filling contrast agent (LAA-GFCA) composed of food-grade ingredients and performed a safety evaluation.
METHODS: Acoustic characterization of LAA-GFCA was performed using the water-immersion insertion substitute method, with phantom experiments designed to evaluate imaging performance. Pre-clinical safety studies were conducted in rabbits, followed by a clinical pilot study in healthy volunteers to assess safety and the optimal imaging window.
RESULTS: Acoustic characterization of LAA-GFCA showed that its speed of sound (1541.2 m/s at 34.9°C) matched human soft tissue, with an ultra-low-attenuation coefficient slope (0.024 dB/(cm·MHz)) at the test frequency of 3.5 MHz. Phantom experiments demonstrated enhanced visualization of cyst-like and gray-scale lesions versus cereal-based echoic gastrointestinal filling contrast agent. Pre-clinical studies in eight rabbits confirmed no acute toxicity. Clinical pilot trials in 10 healthy volunteers verified safety and identified the optimal imaging window as 6-15 min after oral administration, enabling clear visualization of the entire pancreas.
CONCLUSION: LAA-GFCA demonstrates a favorable safety profile in pre-clinical and pilot clinical studies, with promising potential to enhance pancreatic transabdominal ultrasound. Future larger-scale studies are warranted to confirm its diagnostic utility.
METHODS: Acoustic characterization of LAA-GFCA was performed using the water-immersion insertion substitute method, with phantom experiments designed to evaluate imaging performance. Pre-clinical safety studies were conducted in rabbits, followed by a clinical pilot study in healthy volunteers to assess safety and the optimal imaging window.
RESULTS: Acoustic characterization of LAA-GFCA showed that its speed of sound (1541.2 m/s at 34.9°C) matched human soft tissue, with an ultra-low-attenuation coefficient slope (0.024 dB/(cm·MHz)) at the test frequency of 3.5 MHz. Phantom experiments demonstrated enhanced visualization of cyst-like and gray-scale lesions versus cereal-based echoic gastrointestinal filling contrast agent. Pre-clinical studies in eight rabbits confirmed no acute toxicity. Clinical pilot trials in 10 healthy volunteers verified safety and identified the optimal imaging window as 6-15 min after oral administration, enabling clear visualization of the entire pancreas.
CONCLUSION: LAA-GFCA demonstrates a favorable safety profile in pre-clinical and pilot clinical studies, with promising potential to enhance pancreatic transabdominal ultrasound. Future larger-scale studies are warranted to confirm its diagnostic utility.