NCT05261724

Brief Summary

Primary and secondary brain tumors are challenging pathologies regarding diagnosis and treatment. MRI is widely used in the imaging evaluation and surgical planning, due to its spatial resolution and ability of tissular characterization. In this study patients with suspected brain tumors, confirmed by routine MRI evaluation (T1, T2, T2\*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation. By analyzing collected data from MRI evaluation and patient records regarding surgical and histopathological data our aim is to investigate derived imaging biomarkers with impact in the surgical planning and rehabilitation of the patients.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 15, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

27 days

First QC Date

February 20, 2022

Last Update Submit

February 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tract damage

    Assess the damage of tracts at baseline preoperative

    3 months

Secondary Outcomes (1)

  • Craniotomy size

    3 months

Study Arms (2)

Patients with primary brain tumors

Diagnostic Test: MRI

Patients with secondary brain tumors

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

In this study patients with suspected primary and secondary brain tumors, confirmed by routine MRI evaluation (T1, T2, T2\*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation.

Patients with primary brain tumorsPatients with secondary brain tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected primary or secondary brain tumors, confirmed by routine MRI evaluation followed by surgical treatment and histopathological exam.

You may qualify if:

  • brain tumors confirmed by routine MRI evaluation
  • surgical treatment with histopathological diagnosis

You may not qualify if:

  • MRI contraindications
  • past or present neurological or neurosurgical condition, beside the tumor
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCJU Mures

Târgu Mureş, Mureș County, 540136, Romania

RECRUITING

Study Officials

  • Mihail Porutiu

    George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 2, 2022

Study Start

February 15, 2021

Primary Completion

March 14, 2021

Study Completion

March 14, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations