ferric-ammonium-citrate and Abdominal-Neoplasms

Clear identification of bowel has been thought to be essential in diagnosis by abdominal MRI. We have completed the clinical phase III trial of a new oral contrast agent (FerriSeltz) which is a ferric ammonium citrate based bowel contrast agent. FerriSeltz is a powder that is dissolved in 300 ml water to create a grape-flavored effervescent drink. We have evaluated the usefulness of FerriSeltz, and compared groups receiving 600 mg and 1200 mg of ferric ammonium citrate, the use and nonuse of parasympathetic blockers, and patients with and without fasting in 174 patients who underwent abdominal MRI using this agent. FerriSeltz was found to brighten the stomach and duodenum, contribute to the improvement in diagnostic efficacy, be safe as a bowel contrast agent in abdominal MRI, and be associated with an extremely low incidence of side effects (only mild diarrhea in one of 169 patients). No significant differences were found in the contribution to the improvement in diagnostic efficacy between the two dosage groups, the use and nonuse of parasympathetic blockers, or patients with and without fasting. We concluded that ferric ammonium citrate based compound (FerriSeltz) is a promising bowel contrast agent in abdominal MRI.

Topics: Abdominal Neoplasms; Adolescent; Adult; Aged; Aged, 80 and over; Contrast Media; Digestive System; Duodenum; Fasting; Female; Ferric Compounds; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Quaternary Ammonium Compounds; Scopolamine; Stomach

To evaluate the efficacy and safety of two dose levels of an orally administered ferric ammonium citrate-based contrast agent for bowel enhancement on T1-weighted spin-echo magnetic resonance (MR) images in 222 patients with known or suspected abnormality of the upper abdomen.. Adverse reactions were graded for intensity, frequency, duration, and relationship to the contrast agent. Twelve unblinded readers compared enhanced with unenhanced images; all MR images were evaluated by two independent offsite radiologists in a blinded review.. No statistically significant changes in mean vital signs or laboratory values were seen. Forty-eight of 220 patients (22%) reported minor side effects. The readers found increased intraluminal signal intensity and improved contrast enhancement of the gastrointestinal tract and distention and improved signal homogeneity in 101-107 cases (89%-98%) after ingestion; the blinded reviewers' findings were similar.. The contrast agent provided new or additional radiologic information in 142 patients (64%), specific additional information in a detected abnormality in 46 of 142 patients (32%), and information that changed diagnosis, management, or surgical approach in 22 of 142 patients (15%).

Topics: Abdomen; Abdominal Neoplasms; Adolescent; Adult; Aged; Aged, 80 and over; Contrast Media; Digestive System Diseases; Dose-Response Relationship, Drug; Drug Tolerance; Female; Ferric Compounds; Humans; Image Enhancement; Intestines; Magnetic Resonance Imaging; Male; Middle Aged; Pancreatic Diseases; Quaternary Ammonium Compounds; Safety