Diffusion-tensor Imaging in Brain Tumors Evaluation | NCT05261724

Studies
Diffusion-tensor Imaging in Brain Tumors Evaluation

NCT05261724

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 2, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diffusion Tensor Imaging
Tractography
MRI

Interventions

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Mar 14, 2021Actual

Completion Date

Mar 14, 2022Estimated

First Submitted Date

Feb 20, 2022

First Submission Date that Met QC Criteria

Feb 20, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2022

Last Update Posted Date

Mar 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mihail Porutiu, Phd student, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with primary brain tumors			Diagnostic Test: MRI
Patients with secondary brain tumors			Diagnostic Test: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tract damage	Assess the damage of tracts at baseline preoperative	3 months

Secondary Outcomes

Measure	Description	Time Frame
Craniotomy size	Assess the size of craniotomy in patients with postoperative CT follow-up	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mihail Porutiu	Contact	+40722694996		mihai.nobel@gmail.com
Mircea Buruian	Contact	+40744503331		mircea.buruian@umfst.ro

Overall Officials

Name	Affiliation	Role
Mihail Porutiu	George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SCJU Mures	Recruiting	Târgu Mureş	Mureș County	540136	Romania