Staging of rectal cancer by double-contrast MR imaging using the rectally administered superparamagnetic iron oxide contrast agent ferristene and IV gadodiamide injection: results of a multicenter phase II trial

J Magn Reson Imaging. 2000 Nov;12(5):651-60. doi: 10.1002/1522-2586(200011)12:5<651::aid-jmri1>3.0.co;2-r.

Abstract

The aim of this study was to assess the accuracy of double-contrast magnetic resonance imaging (MRI) with rectal application of the superparamagnetic iron oxide contrast agent (SPIO) ferristene and IV gadodiamide for preoperative staging of rectal cancer. In a randomized phase II dose-ranging trial, 113 patients were studied preoperatively with one of four different formulations of ferristene (Abdoscan) as an enema before MRI. T1-weighted spin-echo (T1w SE) and T2w turbo spin-echo (TSE) single-contrast images were obtained as well as T1w SE and gradient-echo (GRE) double-contrast images after IV gadodiamide injection (Omniscan). Images were assessed qualitatively, and TNM tumor stage was compared with histopathology. High-viscosity ferristene formulations were superior to low-viscosity formulations in tumor staging (accuracy 90% vs 74%, P < 0.01). There was no significant difference between high and low iron content ferristene. MRI had a sensitivity of 97%, specificity of 50%, and accuracy of 82% for staging of rectal carcinoma higher than T2 stage. At receiver operator characteristic (ROC) analysis, MR differentiation between T1/T2 and T3/T4 tumor stages yielded a ROC index of 0.848. Double-contrast MRI is an accurate method for preoperative staging of rectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / diagnosis
  • Adenocarcinoma / pathology*
  • Adenocarcinoma / surgery
  • Administration, Rectal
  • Adult
  • Aged
  • Biopsy, Needle
  • Chi-Square Distribution
  • Contrast Media*
  • Dose-Response Relationship, Drug
  • Female
  • Ferric Compounds*
  • Gadolinium DTPA*
  • Humans
  • Image Processing, Computer-Assisted
  • Injections, Intravenous
  • Magnetic Resonance Imaging / methods*
  • Male
  • Middle Aged
  • Neoplasm Staging / methods
  • Preoperative Care
  • Probability
  • ROC Curve
  • Rectal Neoplasms / diagnosis
  • Rectal Neoplasms / pathology*
  • Rectal Neoplasms / surgery
  • Sensitivity and Specificity

Substances

  • Contrast Media
  • Ferric Compounds
  • ferristene
  • gadodiamide
  • Gadolinium DTPA