A multisite phase iii study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for mri of the abdomen and pelvis

William C. Small, Debra DeSimone-Macchi, John R. Parker, Arun Sukerkar, Peter F. Hahn, Daniel L. Rubin, James V. Zelch, Janet E. Kuhlman, Eric K. Outwater, Jeffrey C. Weinreb, Jeffrey J. Brown, Eduard E. De Lange, Paula J. Woodward, Ronald Arildsen, Gregory S. Foster, Val M. Runge, Alex M. Aisen, Lawrence R. Muroff, Ruedi F. Thoeni, Yuri R. PariskyLawrence N. Tanenbaum, Saara Totterman, Robert J. Herfkens, John Knudsen, Robert E. Laster, Andre Duerinckx, Arthur E. Stillman, Charles E. Spritzer, Sanjay Saini, Neil M. Rofsky, Michael E. Bernardino

Research output: Contribution to journalArticle

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Abstract

The purpose of this study was to evaluate the safety and efficacy of a manganese chloride-based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride-based oral contrast agent, LumenHance® (Bracco Diagnostics, Inc.). Safety was determined by comparing pre- and post-dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre- and post-dose T1- and T2weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers). MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8- 20% of patients. No clinically significant post-dose laboratory changes were seen. Fortyeight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.

Original languageEnglish (US)
Pages (from-to)15-24
Number of pages10
JournalJournal of Magnetic Resonance Imaging
Volume10
Issue number1
DOIs
StatePublished - Jul 1999

Fingerprint

Gastrointestinal Agents
Pelvis
Abdomen
Contrast Media
Safety
Placebos
manganese chloride
Research Personnel
Pathology
Phase III Clinical Trials
Confounding Factors (Epidemiology)
Vital Signs
Peptic Ulcer
Inflammatory Bowel Diseases

Keywords

  • Contrast enhancement
  • Gastrointestinal tract, MR
  • Magnetic resonance (MR)
  • Manganese chloride

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

A multisite phase iii study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for mri of the abdomen and pelvis. / Small, William C.; DeSimone-Macchi, Debra; Parker, John R.; Sukerkar, Arun; Hahn, Peter F.; Rubin, Daniel L.; Zelch, James V.; Kuhlman, Janet E.; Outwater, Eric K.; Weinreb, Jeffrey C.; Brown, Jeffrey J.; De Lange, Eduard E.; Woodward, Paula J.; Arildsen, Ronald; Foster, Gregory S.; Runge, Val M.; Aisen, Alex M.; Muroff, Lawrence R.; Thoeni, Ruedi F.; Parisky, Yuri R.; Tanenbaum, Lawrence N.; Totterman, Saara; Herfkens, Robert J.; Knudsen, John; Laster, Robert E.; Duerinckx, Andre; Stillman, Arthur E.; Spritzer, Charles E.; Saini, Sanjay; Rofsky, Neil M.; Bernardino, Michael E.

In: Journal of Magnetic Resonance Imaging, Vol. 10, No. 1, 07.1999, p. 15-24.

Research output: Contribution to journalArticle

Small, WC, DeSimone-Macchi, D, Parker, JR, Sukerkar, A, Hahn, PF, Rubin, DL, Zelch, JV, Kuhlman, JE, Outwater, EK, Weinreb, JC, Brown, JJ, De Lange, EE, Woodward, PJ, Arildsen, R, Foster, GS, Runge, VM, Aisen, AM, Muroff, LR, Thoeni, RF, Parisky, YR, Tanenbaum, LN, Totterman, S, Herfkens, RJ, Knudsen, J, Laster, RE, Duerinckx, A, Stillman, AE, Spritzer, CE, Saini, S, Rofsky, NM & Bernardino, ME 1999, 'A multisite phase iii study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for mri of the abdomen and pelvis', Journal of Magnetic Resonance Imaging, vol. 10, no. 1, pp. 15-24. https://doi.org/10.1002/(SICI)1522-2586(199907)10:1<15::AID-JMRI3>3.0.CO;2-X
Small, William C. ; DeSimone-Macchi, Debra ; Parker, John R. ; Sukerkar, Arun ; Hahn, Peter F. ; Rubin, Daniel L. ; Zelch, James V. ; Kuhlman, Janet E. ; Outwater, Eric K. ; Weinreb, Jeffrey C. ; Brown, Jeffrey J. ; De Lange, Eduard E. ; Woodward, Paula J. ; Arildsen, Ronald ; Foster, Gregory S. ; Runge, Val M. ; Aisen, Alex M. ; Muroff, Lawrence R. ; Thoeni, Ruedi F. ; Parisky, Yuri R. ; Tanenbaum, Lawrence N. ; Totterman, Saara ; Herfkens, Robert J. ; Knudsen, John ; Laster, Robert E. ; Duerinckx, Andre ; Stillman, Arthur E. ; Spritzer, Charles E. ; Saini, Sanjay ; Rofsky, Neil M. ; Bernardino, Michael E. / A multisite phase iii study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for mri of the abdomen and pelvis. In: Journal of Magnetic Resonance Imaging. 1999 ; Vol. 10, No. 1. pp. 15-24.
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T1 - A multisite phase iii study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for mri of the abdomen and pelvis

AU - Small, William C.

AU - DeSimone-Macchi, Debra

AU - Parker, John R.

AU - Sukerkar, Arun

AU - Hahn, Peter F.

AU - Rubin, Daniel L.

AU - Zelch, James V.

AU - Kuhlman, Janet E.

AU - Outwater, Eric K.

AU - Weinreb, Jeffrey C.

AU - Brown, Jeffrey J.

AU - De Lange, Eduard E.

AU - Woodward, Paula J.

AU - Arildsen, Ronald

AU - Foster, Gregory S.

AU - Runge, Val M.

AU - Aisen, Alex M.

AU - Muroff, Lawrence R.

AU - Thoeni, Ruedi F.

AU - Parisky, Yuri R.

AU - Tanenbaum, Lawrence N.

AU - Totterman, Saara

AU - Herfkens, Robert J.

AU - Knudsen, John

AU - Laster, Robert E.

AU - Duerinckx, Andre

AU - Stillman, Arthur E.

AU - Spritzer, Charles E.

AU - Saini, Sanjay

AU - Rofsky, Neil M.

AU - Bernardino, Michael E.

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N2 - The purpose of this study was to evaluate the safety and efficacy of a manganese chloride-based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride-based oral contrast agent, LumenHance® (Bracco Diagnostics, Inc.). Safety was determined by comparing pre- and post-dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre- and post-dose T1- and T2weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers). MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8- 20% of patients. No clinically significant post-dose laboratory changes were seen. Fortyeight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.

AB - The purpose of this study was to evaluate the safety and efficacy of a manganese chloride-based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride-based oral contrast agent, LumenHance® (Bracco Diagnostics, Inc.). Safety was determined by comparing pre- and post-dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre- and post-dose T1- and T2weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers). MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8- 20% of patients. No clinically significant post-dose laboratory changes were seen. Fortyeight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.

KW - Contrast enhancement

KW - Gastrointestinal tract, MR

KW - Magnetic resonance (MR)

KW - Manganese chloride

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