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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Other: Examination

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Recruiting
      • The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
      • Contact: Yong-Dong Li, MD, Ph.D.; Phone Number: 0086-21-64844183; Email: dr_liyongdong@sina.com.cn
      • Contact: Ming-Hua Li, MD, Ph.D.; Phone Number: 0086-21-64844183; Email: liminhua@online.sh.cn
      • Sub-Investigator: Chun Fang, MD.
      • Sub-Investigator: Wu Wang, MD.
      • Principal Investigator: Ming-Hua Li, MD, Ph.D.
      • Principal Investigator: Yong-Dong Li, MD, Ph.D.
      • Sub-Investigator: Hua-Qiao Tan, MD, Ph.D.
      • Sub-Investigator: Shi-Wen Chen, MD, Ph.D.
      • Sub-Investigator: Yuan-Chang Chen, MD.
      • Sub-Investigator: Jia-Ying Zhang, MD.
      • Sub-Investigator: Ding-Jun Hu, MD.
      • Sub-Investigator: Qing Wu, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We estimated that a sample of 350 patients including 12% dropout rate would be enrolled to determine an accuracy of VR 3D-TOF-MRA versus VR RDSA as reference standard with a 95% confidence interval of 5% (i.e., a standard error of approximately 2.5 %) above and below the expected VR 3D-TOF-MRA accuracy of 95%. A P value of 0.05 was considered to indicate statistical significance.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Magnetic resonance angiography; Three-dimensional time-of-flight magnetic resonance angiography(3D-TOF-MRA) was used to detect the intracranial aneurysms in this study	Other: Examination; 3D-TOF-MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography; Other Names: 3D-TOF-MRA

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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):3127-9. doi: 10.1161/STROKEAHA.109.553800. Epub 2009 Jun 25.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ANTICIPATED): December 1, 2010

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 11, 2009
• First Posted (ESTIMATE): December 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 25, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Magnetic resonance angiography; Intracranial aneurysm; Digital subtraction angiography; Volume rendering
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CASC3