Diffusion Tensor ImagingNCT05261724
Diffusion-tensor Imaging in Brain Tumors Evaluation
An observational study of Diffusion Tensor Imaging and Tractography, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffusion Tensor Imaging, Tractography, MRI
- What is being tested?
- MRI
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 15 Feb 2021to 14 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected primary or secondary brain tumors, confirmed by routine MRI evaluation followed by surgical treatment and histopathological exam.
Who may be able to join
- brain tumors confirmed by routine MRI evaluation
- surgical treatment with histopathological diagnosis
Who cannot join
- MRI contraindications
- past or present neurological or neurosurgical condition, beside the tumor
- pregnancy
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
SCJU Mures
Târgu Mureş, Mureș County, 540136
Mihail Porutiu, +40722694996, mihai.nobel@gmail.com
About this study
Official title: Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation
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.
- Conditions
- Diffusion Tensor Imaging, Tractography, MRI
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary brain tumors | Not described Receives: Diagnostic Test: MRI | |
| Patients with secondary brain tumors | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tract damage
Assess the damage of tracts at baseline preoperative
Measured: 3 months
Secondary outcomes (1)
Craniotomy size
Assess the size of craniotomy in patients with postoperative CT follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Feb 2021
- Primary completion14 Mar 2021
- Study completion14 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffusion Tensor ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihail Porutiu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Investigators
- Mihail Porutiu, Principal investigator, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261724
- Sponsor's protocol ID
- GEPaladeU
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation
- ClinicalTrials.gov ID
- NCT05261724
- Acronym / sponsor ID
- GEPaladeU
- Conditions
- Diffusion Tensor Imaging, Tractography, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2022 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with primary brain tumors | – | Diagnostic Test: MRI |
| Patients with secondary brain tumors | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected primary or secondary brain tumors, confirmed by routine MRI evaluation followed by surgical treatment and histopathological exam.
Key inclusion criteria (2 listed)
- brain tumors confirmed by routine MRI evaluation
- surgical treatment with histopathological diagnosis
Key exclusion criteria (3 listed)
- MRI contraindications
- past or present neurological or neurosurgical condition, beside the tumor
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIIn 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. | Diagnostic test | Patients with primary brain tumors, Patients with secondary brain tumors |
Primary outcome
Tract damage
Time frame: 3 months
Assess the damage of tracts at baseline preoperative
1 secondary outcome
Craniotomy size
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihail Porutiu principal investigator
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffusion Tensor Imaging and Tractography, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihail Porutiu (+40722694996, mihai.nobel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tract damage (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.