Fast Brain MRI in Children With Suspected Brain Tumor

NCT ID: NCT05776602

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-31

Brief Summary

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This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

Detailed Description

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The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population.

The primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings.

Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated.

Secondary outcomes will also include the assessment of diagnostic image quality and image artifacts.

The study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain.

Study subjects will be investigated during the same day at 3T MR with Neuromix sequence in addition to the routine MRI examination.

Volume measurements will be compared.

Conditions

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Magnetic Resonance Imaging Brain Neoplasms, Childhood Brain Neoplasms Brain Tumor Diagnosis Image Neuroimaging Pediatric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients with suspected or confirmed brain tumor

New method och standard MRI in clinical care

Fast MRI (Neuromix)

Intervention Type DIAGNOSTIC_TEST

Diagnostic performance, correlation, agreement

Interventions

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Fast MRI (Neuromix)

Diagnostic performance, correlation, agreement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 0-18 years.
* Pediatric subjects with diagnosed or suspected brain tumor
* Referral routine MRI study.

Exclusion Criteria

* MRI planned without sedation
* Aborted MR exam
* Unstable patient
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Falk Delgado

MD, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Falk Delgado, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinksa Universitetssjukhuset

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anna Falk Delgado

Role: CONTACT

0046812370000

Facility Contacts

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Anna Falk Delgado

Role: primary

Other Identifiers

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Fast Brain MRI in children

Identifier Type: -

Identifier Source: org_study_id

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