Fast Brain MRI in Children With Suspected Brain Tumor

NCT05776602 | Unknown

• 1 other identifier: Fast Brain MRI in children
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Neuro; Imaging; MRI; Diagnostic accuracy; Neuroimaging; Fast MRI; Neuromix; Pediatric

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance

  AUC, area under the curve for the comparison of the new method against the reference standard

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Imaging artifacts

  through study completion, an average of 1 year

• Imaging quality

  through study completion, an average of 1 year

• Correlation

  through study completion, an average of 1 year

• Agreement

  through study completion, an average of 1 year

• Sensitivity

  through study completion, an average of 1 year

Study Arms (1)

Pediatric patients with suspected or confirmed brain tumor

New method och standard MRI in clinical care

Diagnostic Test: Fast MRI (Neuromix)

Interventions

Fast MRI (Neuromix) DIAGNOSTIC_TEST

Diagnostic performance, correlation, agreement

Pediatric patients with suspected or confirmed brain tumor

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.

You may qualify if:

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

You may not qualify if:

• MRI planned without sedation
• Aborted MR exam
• Unstable patient

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinksa Universitetssjukhuset

Stockholm, Eugeniavägen 3, Sweden

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Disease

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Falk Delgado, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Falk Delgado

CONTACT

0046812370000; anna.falk.delgado@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, associate professor

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 20, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)