Nasopharyngeal CarcinomaNCT06881225

Regulation of Blood-Brain Barrier Permeability by APOE Gene Polymorphism and Its Impact on Cognitive Function Post-Radiotherapy in Nasopharyngeal Carcinoma: An MRI Study

An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: Using DCE-MRI, fMRI, and DSI, establish a longitudinal brain functional and structural imaging database for three groups of nasopharyngeal carcinoma patients before and 18 months after radiotherapy.
How many people: 300 participants
Where: 1 siteChina
Study dates: 1 Jan 2024to 31 Dec 2026
Phase: Observational
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 20 to 60 years
All sexes
No healthy volunteers
Adult

Study population: Collect nasopharyngeal carcinoma patients who seek medical treatment at Sun Yat - sen University Cancer Center

Who may be able to join

Patients newly diagnosed with nasopharyngeal carcinoma, pathologically confirmed, and who have not received anti - tumor treatments such as surgery, induction chemotherapy, or radiotherapy.
All patients are of Han ethnicity and right - handed. Patients are aged between 20 and 60 years old, with an educational level of junior high school or above.
The clinical stage of the included patients is AJCC 8th edition stage I - IVa, without distant metastasis, and patients are scheduled to receive intensity - modulated radiotherapy (IMRT) according to the clinical plan.
Patients have no other serious systemic diseases except nasopharyngeal carcinoma.
There is no intracranial invasion of nasopharyngeal carcinoma. Routine MRI examinations (including T1WI, T2WI, and FLAIR) are negative. The baseline basic cognitive assessment scales (MoCA and MMSE) before radiotherapy are normal.
Patients have no family history of mental illness. Patients have no history of neurological diseases or head trauma. After fully understanding the experimental content, the subjects agree to participate in this project and sign the informed consent form

Who cannot join

Patients diagnosed with Alzheimer's disease (AD) before being included. AD is diagnosed by psychiatrists according to the 9th Revision of the International Classification of Diseases, Clinical Modification (ICD - 9 - CM).
Patients with intracranial lesions detected by routine MRI examinations. Patients with contraindications to magnetic resonance examinations. Patients with concurrent other diseases. Patients with tumor recurrence who need re - radiotherapy, or those who cannot adhere to and complete IMRT treatment.
Left - handed or ambidextrous patients. Patients with a history of head trauma or mental/neurological diseases. Patients aged less than 20 or more than 60 years old. Patients with serious systemic diseases such as heart, lung, or kidney diseases.
Patients with diabetes or hypertension. Patients who cannot cooperate to complete the neurocognitive scale tests.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Medical Imaging, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Guangzhou, Guangdong, 523000

Other trials in China

About this study

Official title: Study on the Regulation of Blood-Brain Barrier Permeability by APOE Gene Polymorphism and Its Impact on Cognitive Function After Radiotherapy for Nasopharyngeal Carcinoma: An MRI Investigation

adiotherapy-induced cognitive dysfunction is a severe complication following radiotherapy for nasopharyngeal carcinoma (NPC). Our previous studies have demonstrated that abnormalities in brain function and structural connectivity after radiotherapy play a significant role in the occurrence of radiation-induced cognitive dysfunction. However, the key risk factors and underlying neural mechanisms remain unclear. Research has shown that increased blood-brain barrier (BBB) permeability after radiotherapy is an important mechanism leading to cognitive dysfunction, and different APOE gene subtypes can regulate BBB permeability. Therefore, APOE gene polymorphisms are likely to influence post-radiotherapy vascular barrier permeability in NPC patients, thereby affecting their brain function and structural connectivity changes, and ultimately impacting their cognitive function.

This project aims to establish a longitudinal brain imaging database for NPC patients with different APOE genotypes before and after radiotherapy, based on previous research findings. The project will integrate dynamic contrast-enhanced MRI (DCE-MR), resting-state functional MRI (fMRI), and diffusion spectrum imaging (DSI) techniques. By comparing DCE-derived metrics across different genotype groups, the study seeks to identify brain regions with BBB damage differences between APOE genotype groups before and after radiotherapy. Furthermore, it will investigate how BBB damage in these brain regions mediates functional and structural connectivity abnormalities, and their relationship with radiation-induced cognitive dysfunction. The goal is to clarify the neural regulation mechanism of APOE gene polymorphisms in radiation-induced cognitive dysfunction and to identify risk factors for radiation-induced cognitive dysfunction. This research will provide a theoretical basis and valuable reference for the individualized prevention and treatment of radiation-induced cognitive dysfunction.

Conditions: Nasopharyngeal Carcinoma
Being tested: Using DCE-MRI, fMRI, and DSI, establish a longitudinal brain functional and structural imaging database for three groups of nasopharyngeal carcinoma patients before and 18 months after radiotherapy.
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Using DCE-MRI, fMRI, and DSI, establish a longitudinal brain functional and structural imaging database for three groups of nasopharyngeal carcinoma patients before and 18 months after radiotherapy.Other
1. Resting-state fMRI: Use the Gradient Echo Echo Planar Imaging (GRE-EPI) sequence with the following parameters: repetition time (TR) = 2000 ms, echo time (TE) = 30 ms, flip angle (FA) = 90°, slice thickness = 3.0 mm, slice spacing = 0.8 mm, field of view (FOV) = 240 mm × 240 mm, matrix = 128 × 128, in-plane resolution = 64 × 64, 39 axial slices scanned, 240 dynamic scans.
2. DSI: Use diffusion-sensitive imaging (DSI) with 64 diffusion directions, b-values of 0 and 1000 s/mm², TR = 3000 ms, TE = 64 ms, number of excitations (NEX) = 1, matrix = 112 × 112, FOV = 224 mm × 224 mm, slice thickness = 2 mm, no spacing between slices, full brain coverage, and 75 slices scanned.
3. Three-dimensional brain structural MRI:
Sagittal data acquisition is performed with the following parameters: TR = 8.16 ms, TE = 3.18 ms, inversion time (TI) = 800 ms, flip angle (FA) = 8°, matrix = 256 × 256, FOV = 256 mm × 256 mm, voxel size = 1 mm × 1 mm × 1 mm, and 176 slices scanned.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Blood-Brain Barrier Permeability as Measured by Ktrans Values from DCE-MRI
The change in blood-brain barrier permeability will be quantified using the volume transfer constant (Ktrans) derived from Dynamic Contrast-Enhanced MRI (DCE-MRI). Ktrans values will be measured at baseline (pre-radiotherapy) and at 18 months post-radiotherapy. The difference in Ktrans values between these time points will be calculated to assess the change in permeability.
Measured: From enrollment to 18 months after the completion of radiotherapy
Change in Functional Connectivity as Measured by Resting-State fMRI
Functional connectivity will be assessed using resting-state functional MRI (fMRI). The strength of functional connections between specific brain regions, particularly those identified as having significant blood-brain barrier damage, will be measured at baseline and at 18 months post-radiotherapy. The change in functional connectivity strength will be calculated and reported.
Measured: From enrollment to 18 months after the completion of radiotherapy
Change in Structural Connectivity as Measured by Diffusion Spectrum Imaging (DSI)
Structural connectivity will be evaluated using Diffusion Spectrum Imaging (DSI). The integrity of white matter tracts, particularly those connecting regions with significant blood-brain barrier damage, will be measured at baseline and at 18 months post-radiotherapy. The change in structural connectivity, as indicated by metrics such as fractional anisotropy (FA) and mean diffusivity (MD), will be calculated and reported.
Measured: From enrollment to 18 months after the completion of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2026

First posted18 Mar 2025
Study start1 Jan 2024
Primary completion31 Dec 2024
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen 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: Cohort
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06881225
Sponsor's protocol ID: G2024-069-01
Status last verified: Mar 2025
First submitted: 15 Feb 2025
Last updated: 18 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lozupone M, Imbimbo BP, Balducci C, Lo Vecchio F, Bisceglia P, Latino RR, Leone M, Dibello V, Solfrizzi V, Greco A, Daniele A, Watling M, Seripa D, Panza F. Does the imbalance in the apolipoprotein E isoforms underlie the pathophysiological process of sporadic Alzheimer's disease? Alzheimers Dement. 2023 Jan;19(1):353-368. doi: 10.1002/alz.12728. Epub 2022 Jul 28.
PubMed 35900209
Main BS, Villapol S, Sloley SS, Barton DJ, Parsadanian M, Agbaegbu C, Stefos K, McCann MS, Washington PM, Rodriguez OC, Burns MP. Apolipoprotein E4 impairs spontaneous blood brain barrier repair following traumatic brain injury. Mol Neurodegener. 2018 Apr 4;13(1):17. doi: 10.1186/s13024-018-0249-5.
PubMed 29618365
Jackson RJ, Meltzer JC, Nguyen H, Commins C, Bennett RE, Hudry E, Hyman BT. APOE4 derived from astrocytes leads to blood-brain barrier impairment. Brain. 2022 Oct 21;145(10):3582-3593. doi: 10.1093/brain/awab478.
PubMed 34957486
Bell RD, Winkler EA, Singh I, Sagare AP, Deane R, Wu Z, Holtzman DM, Betsholtz C, Armulik A, Sallstrom J, Berk BC, Zlokovic BV. Apolipoprotein E controls cerebrovascular integrity via cyclophilin A. Nature. 2012 May 16;485(7399):512-6. doi: 10.1038/nature11087.
PubMed 22622580
Tang Y, Luo D, Rong X, Shi X, Peng Y. Psychological disorders, cognitive dysfunction and quality of life in nasopharyngeal carcinoma patients with radiation-induced brain injury. PLoS One. 2012;7(6):e36529. doi: 10.1371/journal.pone.0036529. Epub 2012 Jun 11.
PubMed 22701557
Penn IW, Chung CH, Huang YC, Chen MC, Sun CA, Yip PK, Chien WC. Increased risk of dementia in patients with nasopharyngeal cancer treated with radiation therapy: A nationwide population-based cohort study. Arch Gerontol Geriatr. 2021 Mar-Apr;93:104303. doi: 10.1016/j.archger.2020.104303. Epub 2020 Nov 22.
PubMed 33302001
Zheng Z, Wang B, Zhao Q, Zhang Y, Wei J, Meng L, Xin Y, Jiang X. Research progress on mechanism and imaging of temporal lobe injury induced by radiotherapy for head and neck cancer. Eur Radiol. 2022 Jan;32(1):319-330. doi: 10.1007/s00330-021-08164-6. Epub 2021 Jul 29.
PubMed 34327577
Hsiao KY, Yeh SA, Chang CC, Tsai PC, Wu JM, Gau JS. Cognitive function before and after intensity-modulated radiation therapy in patients with nasopharyngeal carcinoma: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):722-6. doi: 10.1016/j.ijrobp.2009.06.080. Epub 2010 Jan 13.
PubMed 20044217
Tofilon PJ, Fike JR. The radioresponse of the central nervous system: a dynamic process. Radiat Res. 2000 Apr;153(4):357-70. doi: 10.1667/0033-7587(2000)153[0357:trotcn]2.0.co;2.
PubMed 10798963
McDowell LJ, Ringash J, Xu W, Chan B, Lu L, Waldron J, Rock K, So N, Huang SH, Giuliani M, Hope A, O'Sullivan B, Bratman SV, Cho J, Kim J, Jang R, Bayley A, Bernstein LJ. A cross sectional study in cognitive and neurobehavioral impairment in long-term nasopharyngeal cancer survivors treated with intensity-modulated radiotherapy. Radiother Oncol. 2019 Feb;131:179-185. doi: 10.1016/j.radonc.2018.09.012. Epub 2018 Sep 29.
PubMed 30279047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Regulation of Blood-Brain Barrier Permeability by APOE Gene Polymorphism and Its Impact on Cognitive Function After Radiotherapy for Nasopharyngeal Carcinoma: An MRI Investigation
ClinicalTrials.gov ID: NCT06881225
Acronym / sponsor ID: G2024-069-01
Conditions: Nasopharyngeal Carcinoma
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 300 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 18 Mar 2025 (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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Collect nasopharyngeal carcinoma patients who seek medical treatment at Sun Yat - sen University Cancer Center

Key inclusion criteria (6 listed)

Patients newly diagnosed with nasopharyngeal carcinoma, pathologically confirmed, and who have not received anti - tumor treatments such as surgery, induction chemotherapy, or radiotherapy.
All patients are of Han ethnicity and right - handed. Patients are aged between 20 and 60 years old, with an educational level of junior high school or above.
The clinical stage of the included patients is AJCC 8th edition stage I - IVa, without distant metastasis, and patients are scheduled to receive intensity - modulated radiotherapy (IMRT) according to the clinical plan.
Patients have no other serious systemic diseases except nasopharyngeal carcinoma.
There is no intracranial invasion of nasopharyngeal carcinoma. Routine MRI examinations (including T1WI, T2WI, and FLAIR) are negative. The baseline basic cognitive assessment scales (MoCA and MMSE) before radiotherapy are normal.

Key exclusion criteria (4 listed)

Patients diagnosed with Alzheimer's disease (AD) before being included. AD is diagnosed by psychiatrists according to the 9th Revision of the International Classification of Diseases, Clinical Modification (ICD - 9 - CM).
Patients with intracranial lesions detected by routine MRI examinations. Patients with contraindications to magnetic resonance examinations. Patients with concurrent other diseases. Patients with tumor recurrence who need re - radiotherapy, or those who cannot adhere to and complete IMRT treatment.
Left - handed or ambidextrous patients. Patients with a history of head trauma or mental/neurological diseases. Patients aged less than 20 or more than 60 years old. Patients with serious systemic diseases such as heart, lung, or kidney diseases.
Patients with diabetes or hypertension. Patients who cannot cooperate to complete the neurocognitive scale tests.

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
Using DCE-MRI, fMRI, and DSI, establish a longitudinal brain functional and structural imaging database for three groups of nasopharyngeal carcinoma patients before and 18 months after radiotherapy.1. Resting-state fMRI: Use the Gradient Echo Echo Planar Imaging (GRE-EPI) sequence with the following parameters: repetition time (TR) = 2000 ms, echo time (TE) = 30 ms, flip angle (FA) = 90°, slice thickness = 3.0 mm, slice spacing = 0.8 mm, field of view (FOV) = 240 mm × 240 mm, matrix = 128 × 128, in-plane resolution = 64 × 64, 39 axial slices scanned, 240 dynamic scans. 2. DSI: Use diffusion-sensitive imaging (DSI) with 64 diffusion directions, b-values of 0 and 1000 s/mm², TR = 3000 ms, TE = 64 ms, number of excitations (NEX) = 1, matrix = 112 × 112, FOV = 224 mm × 224 mm, slice thickness = 2 mm, no spacing between slices, full brain coverage, and 75 slices scanned. 3. Three-dimensional brain structural MRI: Sagittal data acquisition is performed with the following parameters: TR = 8.16 ms, TE = 3.18 ms, inversion time (TI) = 800 ms, flip angle (FA) = 8°, matrix = 256 × 256, FOV = 256 mm × 256 mm, voxel size = 1 mm × 1 mm × 1 mm, and 176 slices scanned.	Other	–

Primary outcome

Change in Blood-Brain Barrier Permeability as Measured by Ktrans Values from DCE-MRI
Time frame: From enrollment to 18 months after the completion of radiotherapy
The change in blood-brain barrier permeability will be quantified using the volume transfer constant (Ktrans) derived from Dynamic Contrast-Enhanced MRI (DCE-MRI). Ktrans values will be measured at baseline (pre-radiotherapy) and at 18 months post-radiotherapy. The difference in Ktrans values between these time points will be calculated to assess the change in permeability.
Change in Functional Connectivity as Measured by Resting-State fMRI
Time frame: From enrollment to 18 months after the completion of radiotherapy
Functional connectivity will be assessed using resting-state functional MRI (fMRI). The strength of functional connections between specific brain regions, particularly those identified as having significant blood-brain barrier damage, will be measured at baseline and at 18 months post-radiotherapy. The change in functional connectivity strength will be calculated and reported.
Change in Structural Connectivity as Measured by Diffusion Spectrum Imaging (DSI)
Time frame: From enrollment to 18 months after the completion of radiotherapy
Structural connectivity will be evaluated using Diffusion Spectrum Imaging (DSI). The integrity of white matter tracts, particularly those connecting regions with significant blood-brain barrier damage, will be measured at baseline and at 18 months post-radiotherapy. The change in structural connectivity, as indicated by metrics such as fractional anisotropy (FA) and mean diffusivity (MD), will be calculated and reported.

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 18 Mar 2025.
Background: PubMed 35900209Lozupone M, Imbimbo BP, Balducci C, Lo Vecchio F, Bisceglia P, Latino RR, Leone M, Dibello V, Solfrizzi V, Greco A, Daniele A, Watling M, Seripa D, Panza F. Does the imbalance in the apolipoprotein E isoforms underlie the pathophysiological process of sporadic Alzheimer's disease? Alzheimers Dement. 2023 Jan;19(1):353-368. doi: 10.1002/alz.12728. Epub 2022 Jul 28.
Background: PubMed 29618365Main BS, Villapol S, Sloley SS, Barton DJ, Parsadanian M, Agbaegbu C, Stefos K, McCann MS, Washington PM, Rodriguez OC, Burns MP. Apolipoprotein E4 impairs spontaneous blood brain barrier repair following traumatic brain injury. Mol Neurodegener. 2018 Apr 4;13(1):17. doi: 10.1186/s13024-018-0249-5.
Background: PubMed 34957486Jackson RJ, Meltzer JC, Nguyen H, Commins C, Bennett RE, Hudry E, Hyman BT. APOE4 derived from astrocytes leads to blood-brain barrier impairment. Brain. 2022 Oct 21;145(10):3582-3593. doi: 10.1093/brain/awab478.
Background: PubMed 22622580Bell RD, Winkler EA, Singh I, Sagare AP, Deane R, Wu Z, Holtzman DM, Betsholtz C, Armulik A, Sallstrom J, Berk BC, Zlokovic BV. Apolipoprotein E controls cerebrovascular integrity via cyclophilin A. Nature. 2012 May 16;485(7399):512-6. doi: 10.1038/nature11087.
Background: PubMed 22701557Tang Y, Luo D, Rong X, Shi X, Peng Y. Psychological disorders, cognitive dysfunction and quality of life in nasopharyngeal carcinoma patients with radiation-induced brain injury. PLoS One. 2012;7(6):e36529. doi: 10.1371/journal.pone.0036529. Epub 2012 Jun 11.
Background: PubMed 33302001Penn IW, Chung CH, Huang YC, Chen MC, Sun CA, Yip PK, Chien WC. Increased risk of dementia in patients with nasopharyngeal cancer treated with radiation therapy: A nationwide population-based cohort study. Arch Gerontol Geriatr. 2021 Mar-Apr;93:104303. doi: 10.1016/j.archger.2020.104303. Epub 2020 Nov 22.
Background: PubMed 34327577Zheng Z, Wang B, Zhao Q, Zhang Y, Wei J, Meng L, Xin Y, Jiang X. Research progress on mechanism and imaging of temporal lobe injury induced by radiotherapy for head and neck cancer. Eur Radiol. 2022 Jan;32(1):319-330. doi: 10.1007/s00330-021-08164-6. Epub 2021 Jul 29.
Background: PubMed 20044217Hsiao KY, Yeh SA, Chang CC, Tsai PC, Wu JM, Gau JS. Cognitive function before and after intensity-modulated radiation therapy in patients with nasopharyngeal carcinoma: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):722-6. doi: 10.1016/j.ijrobp.2009.06.080. Epub 2010 Jan 13.
Background: PubMed 10798963Tofilon PJ, Fike JR. The radioresponse of the central nervous system: a dynamic process. Radiat Res. 2000 Apr;153(4):357-70. doi: 10.1667/0033-7587(2000)153[0357:trotcn]2.0.co;2.
Results publication: PubMed 30279047McDowell LJ, Ringash J, Xu W, Chan B, Lu L, Waldron J, Rock K, So N, Huang SH, Giuliani M, Hope A, O'Sullivan B, Bratman SV, Cho J, Kim J, Jang R, Bayley A, Bernstein LJ. A cross sectional study in cognitive and neurobehavioral impairment in long-term nasopharyngeal cancer survivors treated with intensity-modulated radiotherapy. Radiother Oncol. 2019 Feb;131:179-185. doi: 10.1016/j.radonc.2018.09.012. Epub 2018 Sep 29.
Individual participant dataSharing planned: No

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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 Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. 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 China. 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?

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?

Change in Blood-Brain Barrier Permeability as Measured by Ktrans Values from DCE-MRI (time frame: From enrollment to 18 months after the completion of radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06881225, which also lists 10 linked publications.

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 18 Mar 2025.