Brain TumorNCT03166592
Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance in Adults
An observational study of Brain Tumor, run by Assiut University at 2 sites in Egypt.
Trial summary
Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Magnetic resonance imaging with contrast
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2017to Sep 2019
- 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 to 60 years
- All sexes
- Adult
Study population: All Magnetic resonance imaging detected brain cases referred from Neurosurgery \& Neuropsychiatry departments as well as Outpatient clinics
- Inclusion criteria:
- An intra axial space occupying lesion/lesions detected on conventional structural imaging
- Exclusion criteria:
- MRI contraindications (as pace maker or claustrophobia).
- Contrast hypersensitivity
- Impaired renal function.
- Pediatric age group
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ahmed Abbas
Assiut, Cairo Governorate, 002
ahmed abbas, MD, bmr90@hotmail.com
ahmed abbas
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
Official title: Impact of Advanced Neuroimaging Techniques in Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance Diagnostic Strategy in Adults
Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit.
Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.
Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging
- Conditions
- Brain Tumor
- Being tested
- Magnetic resonance imaging with contrast
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging with contrastDevice
injection of gadolinium contrast then acquisition of images with magnetic resonance imaging then spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with malignant masses
sensitivity of the magnetic resonance spectroscopy in diagnosis of brain malignant masses
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jul 2017
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166592
- Sponsor's protocol ID
- IAM
- Status last verified
- Aug 2017
- First submitted
- 24 May 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Advanced Neuroimaging Techniques in Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance Diagnostic Strategy in Adults
- ClinicalTrials.gov ID
- NCT03166592
- Acronym / sponsor ID
- IAM
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 May 2017 (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.
Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit.
Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.
Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All Magnetic resonance imaging detected brain cases referred from Neurosurgery \& Neuropsychiatry departments as well as Outpatient clinics
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 |
|---|---|---|
| Magnetic resonance imaging with contrastinjection of gadolinium contrast then acquisition of images with magnetic resonance imaging then spectroscopy | Device | – |
Primary outcome
Number of patients with malignant masses
Time frame: 1 hour
sensitivity of the magnetic resonance spectroscopy in diagnosis of brain malignant masses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 Ahmed Abbas, MD (00201003385183, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with malignant masses (time frame: 1 hour). 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 16 Aug 2017.