NCT03166592

Brief Summary

Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit. Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement. Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

May 24, 2017

Last Update Submit

August 13, 2017

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Number of patients with malignant masses

    sensitivity of the magnetic resonance spectroscopy in diagnosis of brain malignant masses

    1 hour

Interventions

Magnetic resonance imaging with contrastDEVICE

injection of gadolinium contrast then acquisition of images with magnetic resonance imaging then spectroscopy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Magnetic resonance imaging detected brain cases referred from Neurosurgery \& Neuropsychiatry departments as well as Outpatient clinics

You may qualify if:

  • \* An intra axial space occupying lesion/lesions detected on conventional structural imaging

You may not qualify if:

  • MRI contraindications (as pace maker or claustrophobia).
  • Contrast hypersensitivity
  • Impaired renal function.
  • Pediatric age group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ahmed Abbas, MD

CONTACT

00201003385183bmr90@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 25, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)