GlioblastomaNCT04846257
Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence
An observational study of Glioblastoma, run by Egyptian Medical Syndicate at 1 site in Egypt.
Trial summary
Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Dynamic contrast-enhanced MRI
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed glioblastoma
Who may be able to join
- Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI.
- The lesions should be surgically resected at the time of the presentation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Neurosurgery, Cairo University Faculty of Medicine
Cairo
About this study
Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)
- Conditions
- Glioblastoma
- Being tested
- Dynamic contrast-enhanced MRI
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast-enhanced MRIOther
Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is the acquisition of sequential images during the passage of a contrast agent within a tissue of interest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of tumor
Measured: 2018-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Medical Syndicate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed A. Azab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846257
- Sponsor's protocol ID
- DCE_MRI_GBM
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence
- ClinicalTrials.gov ID
- NCT04846257
- Acronym / sponsor ID
- DCE_MRI_GBM
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Egyptian Medical SyndicateUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 15 Apr 2021 (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.
Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed glioblastoma
Key inclusion criteria (2 listed)
- Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI.
- The lesions should be surgically resected at the time of the presentation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dynamic contrast-enhanced MRIDynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is the acquisition of sequential images during the passage of a contrast agent within a tissue of interest. | Other | – |
Primary outcome
Recurrence of tumor
Time frame: 2018-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glioblastoma, run by Egyptian Medical Syndicate at 1 site in Egypt.
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 0 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: finished, as of the sponsor's last update on 19 Apr 2021. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of tumor (time frame: 2018-2021). 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 19 Apr 2021.