Abstract
Rationale and Objectives: To evaluate 4 doses of gadobenate dimeglumine (Gd-BOPTA) for contrast-enhanced magnetic resonance angiography (CE-MRA) of the pelvic arteries and to compare CE-MRA with unenhanced time-of-flight MRA (2D-TOF-MRA). Methods: A multicenter Phase II dose-finding study was performed in 136 patients with Gd-BOPTA doses of 0.025, 0.05, 0.1, and 0.2 mmuol/kg bodyweight. Evaluation of CE-MRA images and comparison with 2D-TOF-MRA images was performed onsite and by 2 blinded offsite reviewers in terms of subjective image quality, number of lesions detected, and confidence in lesion characterization. Results: Significant (P <0.05) improvements over unenhanced findings were observed for CE-MRA at all dose levels. For reviewer I and the onsite investigators, the overall image quality increased up to a dose of 0.1 mmol/kg and then plateaued. For reviewer 2, increased image quality was noted up to a dose of 0.2 mmol/kg. Significant (P <0.005) increases in diagnostic confidence on CE-MRA versus unenhanced MRA was observed for all dose groups by reviewer 1 and the onsite investigators and for the 0.1 and 0.2 mmol/kg dose groups by reviewer 2. No serious adverse events were recorded that were attributable to the study drug and no trends in laboratory parameters, vital signs, or electrocardiogram recordings were observed. Conclusions: Gadobenate dimeglumine-enhanced MRA is safe and significantly more effective than unenhanced 2D-TOF-MRA for imaging the pelvic arteries. A dose of 0.1 mmol/kg appears the most appropriate dose for subsequent Phase III clinical evaluation.
| Original language | English |
|---|---|
| Pages (from-to) | 504-515 |
| Number of pages | 12 |
| Journal | Investigative Radiology |
| Volume | 38 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 1 2003 |
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Keywords
- Contrast media
- Gadobenate dimeglumine
- Gd-BOPTA
- Iliac artery
- Magnetic resonance angiography
- Phase II clinical trial
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Radiological and Ultrasound Technology
Cite this
Gadobenate dimeglumine-enhanced magnetic resonance angiography of the pelvic arteries. / Wikström, Johan; Wasser, Martin N.; Pattynama, Peter M T; Bonomo, Lorenzo; Hamm, Bernd; Del Maschio, Alessandro; Knopp, Michael V.; Marchal, Guy; Barentsz, Jelle O.; Oudkerk, Matthijs; Hentrich, Hans Rainer; Daprà, Massimo; Kirchin, Miles A.; Shen, Ningyan; Spinazzi, Alberto; Ahlström, Håkan.
In: Investigative Radiology, Vol. 38, No. 8, 01.08.2003, p. 504-515.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Gadobenate dimeglumine-enhanced magnetic resonance angiography of the pelvic arteries
AU - Wikström, Johan
AU - Wasser, Martin N.
AU - Pattynama, Peter M T
AU - Bonomo, Lorenzo
AU - Hamm, Bernd
AU - Del Maschio, Alessandro
AU - Knopp, Michael V.
AU - Marchal, Guy
AU - Barentsz, Jelle O.
AU - Oudkerk, Matthijs
AU - Hentrich, Hans Rainer
AU - Daprà, Massimo
AU - Kirchin, Miles A.
AU - Shen, Ningyan
AU - Spinazzi, Alberto
AU - Ahlström, Håkan
PY - 2003/8/1
Y1 - 2003/8/1
N2 - Rationale and Objectives: To evaluate 4 doses of gadobenate dimeglumine (Gd-BOPTA) for contrast-enhanced magnetic resonance angiography (CE-MRA) of the pelvic arteries and to compare CE-MRA with unenhanced time-of-flight MRA (2D-TOF-MRA). Methods: A multicenter Phase II dose-finding study was performed in 136 patients with Gd-BOPTA doses of 0.025, 0.05, 0.1, and 0.2 mmuol/kg bodyweight. Evaluation of CE-MRA images and comparison with 2D-TOF-MRA images was performed onsite and by 2 blinded offsite reviewers in terms of subjective image quality, number of lesions detected, and confidence in lesion characterization. Results: Significant (P <0.05) improvements over unenhanced findings were observed for CE-MRA at all dose levels. For reviewer I and the onsite investigators, the overall image quality increased up to a dose of 0.1 mmol/kg and then plateaued. For reviewer 2, increased image quality was noted up to a dose of 0.2 mmol/kg. Significant (P <0.005) increases in diagnostic confidence on CE-MRA versus unenhanced MRA was observed for all dose groups by reviewer 1 and the onsite investigators and for the 0.1 and 0.2 mmol/kg dose groups by reviewer 2. No serious adverse events were recorded that were attributable to the study drug and no trends in laboratory parameters, vital signs, or electrocardiogram recordings were observed. Conclusions: Gadobenate dimeglumine-enhanced MRA is safe and significantly more effective than unenhanced 2D-TOF-MRA for imaging the pelvic arteries. A dose of 0.1 mmol/kg appears the most appropriate dose for subsequent Phase III clinical evaluation.
AB - Rationale and Objectives: To evaluate 4 doses of gadobenate dimeglumine (Gd-BOPTA) for contrast-enhanced magnetic resonance angiography (CE-MRA) of the pelvic arteries and to compare CE-MRA with unenhanced time-of-flight MRA (2D-TOF-MRA). Methods: A multicenter Phase II dose-finding study was performed in 136 patients with Gd-BOPTA doses of 0.025, 0.05, 0.1, and 0.2 mmuol/kg bodyweight. Evaluation of CE-MRA images and comparison with 2D-TOF-MRA images was performed onsite and by 2 blinded offsite reviewers in terms of subjective image quality, number of lesions detected, and confidence in lesion characterization. Results: Significant (P <0.05) improvements over unenhanced findings were observed for CE-MRA at all dose levels. For reviewer I and the onsite investigators, the overall image quality increased up to a dose of 0.1 mmol/kg and then plateaued. For reviewer 2, increased image quality was noted up to a dose of 0.2 mmol/kg. Significant (P <0.005) increases in diagnostic confidence on CE-MRA versus unenhanced MRA was observed for all dose groups by reviewer 1 and the onsite investigators and for the 0.1 and 0.2 mmol/kg dose groups by reviewer 2. No serious adverse events were recorded that were attributable to the study drug and no trends in laboratory parameters, vital signs, or electrocardiogram recordings were observed. Conclusions: Gadobenate dimeglumine-enhanced MRA is safe and significantly more effective than unenhanced 2D-TOF-MRA for imaging the pelvic arteries. A dose of 0.1 mmol/kg appears the most appropriate dose for subsequent Phase III clinical evaluation.
KW - Contrast media
KW - Gadobenate dimeglumine
KW - Gd-BOPTA
KW - Iliac artery
KW - Magnetic resonance angiography
KW - Phase II clinical trial
UR - http://www.scopus.com/inward/record.url?scp=10744225127&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=10744225127&partnerID=8YFLogxK
U2 - 10.1097/00004424-200308000-00005
DO - 10.1097/00004424-200308000-00005
M3 - Article
C2 - 12874517
AN - SCOPUS:10744225127
VL - 38
SP - 504
EP - 515
JO - Investigative Radiology
JF - Investigative Radiology
SN - 0020-9996
IS - 8
ER -