Diffusion-tensor Imaging in Brain Tumors Evaluation

• Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05261724
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffusion Tensor Imaging; Tractography; MRI	Diagnostic Test: MRI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation
• Actual Study Start Date: Feb 15, 2021
• Actual Primary Completion Date: Mar 14, 2021
• Anticipated Study Completion Date: Mar 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with primary brain tumors	Diagnostic Test: MRI; 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 secondary brain tumors	Diagnostic Test: MRI; 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.

Outcome Measures

Primary Outcome Measures

1. Tract damage [3 months]

   Assess the damage of tracts at baseline preoperative

Secondary Outcome Measures

1. Craniotomy size [3 months]

   Assess the size of craniotomy in patients with postoperative CT follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SCJU Mures	Targu Mures	Mures	Romania	540136

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Mihail Porutiu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mihail Porutiu, Phd student, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
• ClinicalTrials.gov Identifier: NCT05261724
• Other Study ID Numbers: GEPaladeU
• First Posted: Mar 2, 2022
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Mar 2, 2022