Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection

Intracranial Aneurysms Clinical Trial

Official title:

Detection of Intracranial Aneurysm With Non-enhanced, Three-dimensional Time-of-flight Magnetic Resonance Angiography(3D−TOF−MRA): a Prospective Comparison With Three-dimensional Reconstructed Digital Subtraction Angiography (3D RDSA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01031147
• Other study ID #: CASC3
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2009
• Last updated: February 25, 2010
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yong-Dong Li, MD, Ph.D.
• Phone: 0086-21-64844183
• Email: dr_liyongdong[@]sina.com.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

The Chinese Cerebral Aneurysms Survey is a continuing prospective study to evaluate the effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) with volume rendering (VR) at 3-T in the detection of intracranial aneurysms.

Description:

Recent years,three-dimensional time-of-flight MRA (3D-TOF-MRA) has become a useful, contrast-free method for observing intracranial vessels and is widely utilized as a screening examination for intracranial aneurysms. The studies available in Medline show mixed results.Some of these studies just included MRI/MRA in the analysis, which have a high rate of false-positives and are unreliable, and some were lack of control (ruptured aneurysm), precise numbers of false-positive results, standard images process and review, or corroborative IADSA in some patients. Furthermore, most previous studies included small sample size with aneurysm detection at 0.5-T or 1.5-T MR. Thus, these results have been inconclusive because of certain pitfalls in these studies.

Since 2007, we have conducted a clinical study to objective detection of intracranial aneurysms in our routine diagnostic work-up of intracranial aneurysms by our neuroradiologists using a standard procedure with 3D-TOF-MRA with VR at 3T. The investigators want to establish the quality data to prospectively compare 3D-TOF-MRA with VR at 3T vs 3D-RDSA in the diagnosis of intracranial aneurysms in a largest cohort of patients and test it accuracy in screening for suspected patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Suspected or known intracranial aneurysms

Exclusion Criteria:

• Patient's inability to cooperate

• Chronic renal failure patients

• Any patients with a contraindication to MRA examination, such as pacemaker, orbital metallic foreign body, coronary stent, etc.

• Any patients with a contraindication to DSA examination, such as allergic to contrast medium, etc.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Other:
• Examination
3D-TOF-MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography

Locations

Country	Name	City	State
China	The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Li MH, Cheng YS, Li YD, Fang C, Chen SW, Wang W, Hu DJ, Xu HW. Large-cohort comparison between three-dimensional time-of-flight magnetic resonance and rotational digital subtraction angiographies in intracranial aneurysm detection. Stroke. 2009 Sep;40(9): — View Citation