OBJECTIVE: Our purpose was to study the safety and efficacy of a new orally administered sonographic contrast agent in patients with suspected upper abdominal disorders. SUBJECTS AND METHODS: Ninety-nine patients with signs or symptoms suggestive of upper abdominal disorders were enrolled in a prospective range-of-dose phase II clinical trial at six sites; sonograms of 93 patients were evaluated for efficacy. Patients underwent upper abdominal sonography before and after receiving a randomized dose of the contrast agent (200, 400, 600, 800, or 1000 ml). Safety was monitored by physical examination and laboratory testing. The primary efficacy parameter was additional information provided by the contrast agent when comparing unenhanced and contrast-enhanced sonography. RESULTS: Of the 14 adverse events in 11 patients, only five, which included mild diarrhea and nausea, were considered related to the contrast agent. In 83 of 93 patients, additional information was obtained from the contrast-enhanced images. Visualization of anatomy was improved as follows: the stomach, in 82% of patients; the duodenum, in 63% of patients; the pancreatic head and body, in 61% of patients; and the pancreatic tail, in 67% of patients. CONCLUSION:SonoRx is a safe and well-tolerated contrast agent that improves the sonographic evaluation of the upper abdomen, with significant improvement in imaging the stomach, duodenum, and pancreas.
RCT Entities:
OBJECTIVE: Our purpose was to study the safety and efficacy of a new orally administered sonographic contrast agent in patients with suspected upper abdominal disorders. SUBJECTS AND METHODS: Ninety-nine patients with signs or symptoms suggestive of upper abdominal disorders were enrolled in a prospective range-of-dose phase II clinical trial at six sites; sonograms of 93 patients were evaluated for efficacy. Patients underwent upper abdominal sonography before and after receiving a randomized dose of the contrast agent (200, 400, 600, 800, or 1000 ml). Safety was monitored by physical examination and laboratory testing. The primary efficacy parameter was additional information provided by the contrast agent when comparing unenhanced and contrast-enhanced sonography. RESULTS: Of the 14 adverse events in 11 patients, only five, which included mild diarrhea and nausea, were considered related to the contrast agent. In 83 of 93 patients, additional information was obtained from the contrast-enhanced images. Visualization of anatomy was improved as follows: the stomach, in 82% of patients; the duodenum, in 63% of patients; the pancreatic head and body, in 61% of patients; and the pancreatic tail, in 67% of patients. CONCLUSION: SonoRx is a safe and well-tolerated contrast agent that improves the sonographic evaluation of the upper abdomen, with significant improvement in imaging the stomach, duodenum, and pancreas.