GlioblastomaNCT07731555
Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
A study testing Multimodal Blood Brain Barrier Assessment in people with Glioblastoma, run by Patrick Morris at 1 site in Ireland.
Trial summary
This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection. The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Multimodal Blood Brain Barrier Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2022to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients aged 18 years or older.
- Newly diagnosed glioblastoma.
- Selected for surgical tumor resection.
- Able and willing to provide written informed consent.
- Able to undergo study assessments and follow-up procedures.
Who cannot join
- Contraindication to magnetic resonance imaging.
- Confusion, delirium, or altered state of consciousness that interferes with the ability to provide informed consent.
- Any condition that, in the opinion of the investigator, would prevent completion of study procedures or compromise participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN) contact
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, D09
Aisling Hegarty, RGN, BSc, MSc, PhD, 017977800, Aislinghegarty@rcsi.ie
About this study
This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection. The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate relationships between BBB integrity, tumor biology, and neurological function. Participants will undergo serial assessments before surgery, after surgery, and following radiotherapy. Tumor tissue collected during standard-of-care resection will undergo immunohistochemical and transcriptional
Read the detailed description
Glioblastoma is characterized by disruption of the blood-brain barrier, which may influence tumor progression, neurological dysfunction, treatment delivery, and clinical outcomes. This study seeks to comprehensively characterize BBB integrity using multimodal approaches.
Participants with newly diagnosed GBM selected for surgical resection will undergo:
- Clinical and demographic data collection.
- Neurocognitive assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Reading the Mind in the Eyes Test (RMET).
- High-resolution 3-Tesla MRI with and without gadolinium contrast, including structural and functional imaging sequences.
- Blood sampling for measurement of biomarkers associated with BBB disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase.
- Collection of tumor tissue during routine surgical resection for immunohistochemical and transcriptional analyses.
Serial evaluations will be performed preoperatively, postoperatively, at 72 hours, at 4 weeks, and 4 weeks following completion of radiotherapy, according to the assessment schedule.
- Conditions
- Glioblastoma
- Being tested
- Multimodal Blood Brain Barrier Assessment
- Keywords
- Blood Brain Barrier, Glioblastoma, High Grade Glioma
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Blood Brain Barrier AssessmentDiagnostic test
A standardised multimodal diagnostic assessment designed to characterize blood brain barrier integrity in patients with newly diagnosed glioblastoma. The intervention includes advanced contrast enhanced MRI, serial blood sampling for measurement of blood-brain barrier and neuronal injury biomarkers (including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase), neurocognitive assessments, and immunohistochemical and transcriptional analyses of tumor tissue obtained during standard-of-care surgical resection. Assessments are performed longitudinally before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Blood Brain Barrier Characterisation Cohort | Experimental | Participants with newly diagnosed glioblastoma will undergo a standardized Phase 2 multimodal assessment program designed to characterize blood-brain barrier integrity. Study interventions include serial advanced contrast-enhanced MRI, blood biomarker sampling, neurocognitive assessments, and molecular analysis of tumor tissue obtained during standard of care surgical resection. Assessments will be performed longitudinally at predefined time points before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy to evaluate changes in blood-brain barrier function and their association with clinical, radiological, and molecular outcomes. Receives: Diagnostic Test: Multimodal Blood Brain Barrier Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
Serial measurement of serum biomarkers associated with blood-brain barrier disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase. Biomarker concentrations will be assessed longitudinally to characterize changes in blood-brain barrier integrity in patients with newly diagnosed glioblastoma undergoing surgical resection and radiotherapy.
Measured: Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy
Secondary outcomes (4)
MRI Based Measures of Blood-Brain Barrier Integrity
Assessment of blood-brain barrier disruption using contrast-enhanced 3-Tesla MRI, including quantitative and qualitative radiological measures of tumour enhancement and permeability. Imaging findings will be evaluated longitudinally and correlated with circulating biomarkers and clinical outcomes.
Measured: 4 weeks after surgery
Immunohistochemical Characterisation of Blood-Brain Barrier Disruption
Expression of blood-brain barrier-associated proteins within resected glioblastoma tissue assessed by immunohistochemical analysis. Findings will be used to characterize blood-brain barrier integrity and correlated with circulating biomarker and imaging measures.
Measured: During surgical resection (single assessment)
Transcriptional Characterisation of Blood-Brain Barrier Disruption
Gene expression profiling of resected glioblastoma tissue to identify transcriptional signatures associated with blood-brain barrier disruption and tumour biology. Results will be correlated with blood biomarker and imaging findings.
Measured: During surgical resection (single assessment)
Neurocognitive Function Assessed by RBANS
Neurocognitive performance measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Changes in cognitive function will be examined in relation to blood-brain barrier integrity and treatment.
Measured: Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Mar 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2035 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 2, single-arm, open label interventional study designed to evaluate blood-brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma. All participants will undergo a standardized intervention schedule consisting of advanced contrast-enhanced MRI, serial blood biomarker assessments, neurocognitive testing, and tumor tissue collection and analysis in conjunction with standard-of-care surgical resection and subsequent treatment. The study will evaluate longitudinal changes in BBB integrity and their association with radiological, molecular, and neurocognitive outcomes across multiple predefined time points from diagnosis through completion of radiotherapy.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Morris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Morris, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731555
- Sponsor's protocol ID
- 22-54
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators, institutional policies, ethical approvals, and applicable data protection regulations. Data sharing will include relevant clinical, imaging, biomarker, and neurocognitive datasets necessary to support replication of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Blood-Brain Barrier in High-Grade Glioma Through Immunohistochemical, Transcriptional, Fluorescein and Radiological Analyses
- ClinicalTrials.gov ID
- NCT07731555
- Acronym / sponsor ID
- 22-54
- Conditions
- Glioblastoma
- Keywords
- Blood Brain Barrier, Glioblastoma, High Grade Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Patrick MorrisUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 28 Jul 2026 (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.
This prospective study aims to characterize blood brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma multiforme undergoing surgical resection. The study integrates advanced MRI, circulating BBB biomarkers, neurocognitive assessment, and molecular analysis of tumor tissue to investigate relationships between BBB integrity, tumor biology, and neurological function. Participants will undergo serial assessments before surgery, after surgery, and following radiotherapy. Tumor tissue collected during standard-of-care resection will undergo immunohistochemical and transcriptional
Detailed description
Glioblastoma is characterized by disruption of the blood-brain barrier, which may influence tumor progression, neurological dysfunction, treatment delivery, and clinical outcomes. This study seeks to comprehensively characterize BBB integrity using multimodal approaches.
Participants with newly diagnosed GBM selected for surgical resection will undergo:
- Clinical and demographic data collection.
- Neurocognitive assessment using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Reading the Mind in the Eyes Test (RMET).
- High-resolution 3-Tesla MRI with and without gadolinium contrast, including structural and functional imaging sequences.
- Blood sampling for measurement of biomarkers associated with BBB disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase.
- Collection of tumor tissue during routine surgical resection for immunohistochemical and transcriptional analyses.
Serial evaluations will be performed preoperatively, postoperatively, at 72 hours, at 4 weeks, and 4 weeks following completion of radiotherapy, according to the assessment schedule.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2, single-arm, open label interventional study designed to evaluate blood-brain barrier (BBB) disruption in patients with newly diagnosed glioblastoma. All participants will undergo a standardized intervention schedule consisting of advanced contrast-enhanced MRI, serial blood biomarker assessments, neurocognitive testing, and tumor tissue collection and analysis in conjunction with standard-of-care surgical resection and subsequent treatment. The study will evaluate longitudinal changes in BBB integrity and their association with radiological, molecular, and neurocognitive outcomes across multiple predefined time points from diagnosis through completion of radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Blood Brain Barrier Characterisation Cohort | Experimental | Diagnostic Test: Multimodal Blood Brain Barrier AssessmentParticipants with newly diagnosed glioblastoma will undergo a standardized Phase 2 multimodal assessment program designed to characterize blood-brain barrier integrity. Study interventions include serial advanced contrast-enhanced MRI, blood biomarker sampling, neurocognitive assessments, and molecular analysis of tumor tissue obtained during standard of care surgical resection. Assessments will be performed longitudinally at predefined time points before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy to evaluate changes in blood-brain barrier function and their association with clinical, radiological, and molecular outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older.
- Newly diagnosed glioblastoma.
- Selected for surgical tumor resection.
- Able and willing to provide written informed consent.
- Able to undergo study assessments and follow-up procedures.
Key exclusion criteria (3 listed)
- Contraindication to magnetic resonance imaging.
- Confusion, delirium, or altered state of consciousness that interferes with the ability to provide informed consent.
- Any condition that, in the opinion of the investigator, would prevent completion of study procedures or compromise participant safety.
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 |
|---|---|---|
| Multimodal Blood Brain Barrier AssessmentA standardised multimodal diagnostic assessment designed to characterize blood brain barrier integrity in patients with newly diagnosed glioblastoma. The intervention includes advanced contrast enhanced MRI, serial blood sampling for measurement of blood-brain barrier and neuronal injury biomarkers (including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase), neurocognitive assessments, and immunohistochemical and transcriptional analyses of tumor tissue obtained during standard-of-care surgical resection. Assessments are performed longitudinally before surgery, after surgery, at 72 hours, at 4 weeks, and following completion of radiotherapy. | Diagnostic test | Blood Brain Barrier Characterisation Cohort |
Primary outcome
Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury
Time frame: Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy
Serial measurement of serum biomarkers associated with blood-brain barrier disruption and neuronal injury, including S100β, GFAP, UCHL1, amyloid beta, phosphorylated tau, and neuron-specific enolase. Biomarker concentrations will be assessed longitudinally to characterize changes in blood-brain barrier integrity in patients with newly diagnosed glioblastoma undergoing surgical resection and radiotherapy.
4 secondary outcomes
MRI Based Measures of Blood-Brain Barrier Integrity
Time frame: 4 weeks after surgery
Immunohistochemical Characterisation of Blood-Brain Barrier Disruption
Time frame: During surgical resection (single assessment)
Transcriptional Characterisation of Blood-Brain Barrier Disruption
Time frame: During surgical resection (single assessment)
Neurocognitive Function Assessed by RBANS
Time frame: Baseline (within 7 days before surgery), 4 weeks after surgery, and 4 weeks after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request, subject to approval by the study investigators, institutional policies, ethical approvals, and applicable data protection regulations. Data sharing will include relevant clinical, imaging, biomarker, and neurocognitive datasets necessary to support replication of study findings.
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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.
Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Blood Brain Barrier Assessment in people with Glioblastoma, run by Patrick Morris at 1 site in Ireland.
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 5 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Donncha O'Brien, MB, BCh, BAO, MCh, FRCSI (SN) (018093000, cancerdirectorate@beaumont.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Biomarkers of Blood-Brain Barrier Disruption and Neuronal Injury (time frame: Baseline (within 7 days before surgery), intraoperative, within 24 hours after surgery, 72 hours after surgery, 4 weeks after surgery, and 4 weeks after completion of radiotherapy). 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 28 Jul 2026.