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

February 25, 2010 updated by: Shanghai Jiao Tong University School of Medicine

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASC3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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