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出境医 / 临床实验 / Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy

Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy

Study Description
Brief Summary:
the study aim to evaluate the prevalence of cerebral remote microhaemorrhages (RMH) and remote haematomas (RH) using magnetic resonance susceptibility-weighted imaging (SWI) among patients treated for gliomas during follow-up.

Condition or disease Intervention/treatment
Glioma Diagnostic Test: Cere

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. number of microhaemorrhages (RMH) on magnetic resonance imaging [ Time Frame: one year ]
  2. number of remote haematomas (RH) on magnetic resonance imaging [ Time Frame: one year ]

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 31, 2019
First Posted Date June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date January 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019)
  • number of microhaemorrhages (RMH) on magnetic resonance imaging [ Time Frame: one year ]
  • number of remote haematomas (RH) on magnetic resonance imaging [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy
Official Title Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy
Brief Summary the study aim to evaluate the prevalence of cerebral remote microhaemorrhages (RMH) and remote haematomas (RH) using magnetic resonance susceptibility-weighted imaging (SWI) among patients treated for gliomas during follow-up.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with glioma and folllow up with magnetic resonance imaging
Condition Glioma
Intervention Diagnostic Test: Cere
Magnetic Rseonance imaging for brain tumour follow-up
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2019)
58
Original Actual Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • glioma

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03973892
Other Study ID Numbers 29651771
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date May 2019