Neurocognitive DysfunctionNCT03606421
CBF and NCF Changes With Brain Radiation
An observational study of Neurocognitive Dysfunction and Brain Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will be a dual-arm prospective longitudinal cohort study for patients with brain metastases, at least one of which is appropriate for radiotherapy, to explore brain and cognitive changes following SRS or WBRT and evaluate the feasibility of a novel MRI protocol to identify potential radiological biomarkers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurocognitive Dysfunction, Brain Metastases
- What is being tested?
- SRS and neurocognitive assessments and WBRT and neurocognitive assessments
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain metastases, at least one of which is appropriate for radiotherapy
Who may be able to join
- Patients with brain metastases will be included in this study. Patients with known malignancies but without brain metastases, or patients with primary brain tumors are not eligible for enrollment.
- MRI confirmed 1-10 lesions. Each lesion must not be intended for resection.
- No prior radiation therapy for brain tumours.
- For patients enrolled to arm B, ability to tolerate RespirAct. Based on studies in patients with severe cerebrovascular disease, an 8 - 16% drop-out rate at the time of the first exposure to RespirAct CVR testing is expected [9]. The fourth generation of this device has been associated with increased tolerability secondary to elimination of a physical rebreathing circuit replaced by a digital re-breath analog. This improvement is expected to achieve a drop-out rate significantly below 10%.
- Patients must have a GPA greater than or equal to 1.0.
- Patients must be able to provide informed consent. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
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- Patients must have sufficient fluency in English and sufficient motor and visual functioning (corrected or assisted as required) to complete the NCF-A battery.
- Patients must be accessible for treatment, AE assessment and follow- up.
- Limit to KPS ≥ 70 for patients in arm B; no limit for arm A
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive. Women of childbearing potential will have a pregnancy test to determine eligibility.
Who cannot join
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
- Pregnant patients will be excluded from this study.
- Prior cranial radiotherapy
- Inability to complete MRI with contrast of the head, or a known allergy to gadolinium
- Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor.
- Patients with known malignancies but without brain metastases.
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- Image Findings
- Widespread definitive leptomeningeal metastasis
- A brain metastasis that is located ≤ 2 mm of the optic chiasm
- Evidence of midline shift
- Fourth ventricular narrowing, concerning for hydrocephalus
- Patients who have undergone surgical resection of brain tumor are not eligible for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Novel MRI Techniques Before and After Brain Radiotherapy With Parallel Assessments of Neurocognitive Function
This study will be a dual-arm prospective longitudinal cohort study for patients with brain metastases, at least one of which is appropriate for radiotherapy, to explore brain and cognitive changes following SRS or WBRT and evaluate the feasibility of a novel MRI protocol to identify potential radiological biomarkers of NCF decline.
Patients diagnosed with brain mets will be assigned to either Arm A or Arm B, depending on their treatment plan. Patients in Arm A will be treated with SRS. Patients in Arm B will be treated with WBRT.
Patients' neurocognitive function will be assessed before their radiation treatment and followed up for 2 years post treatment.
- Conditions
- Neurocognitive Dysfunction, Brain Metastases
- Being tested
- SRS and neurocognitive assessments, WBRT and neurocognitive assessments
- Medical subject headings
- Cognition Disorders, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRS and neurocognitive assessmentsRadiation
Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.
WBRT and neurocognitive assessmentsRadiation
Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Patients in Arm A will be treated with stereotactic radiosurgery (SRS) which is a modern method of treating brain lesions that delivers a high amount of radiation to a small volume of the brain affected by a tumour; and is the standard of care for patients with a limited number of brain metastases. Receives: Radiation: SRS and neurocognitive assessments | |
| Arm B. | Patients in Arm B will be treated with whole brain radiotherapy, due to the number of lesions in their brain. Receives: Radiation: WBRT and neurocognitive assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in neurocognitive function (NCF)
To characterize change in NCF from baseline (pre-SRS treatment), to 24 months following using the NCF-A Battery
Measured: Over 24 months
Secondary outcomes (4)
Symptomatic Radiation Toxicity
A diagnosis of symptomatic radiation toxicity will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation
Measured: 3-24 months
Local Failure
Local failure will be defined as one of the following (follow-up MRI or CT brain scans will be compared to the prior MRI or CT brain scan): Increase of > 25% in the size of any lesion or a new, non- contiguous lesion developed outside the radiosurgical bed (in the brain or meninges). Radionecrosis will not be considered tumor progression.
Measured: up to 24 months
Distant Failure
Distant disease is considered to be new metastatic lesions in the brain or outside the brain following WBRT and SRS.
Measured: up to 24 months
Survival
Survival time will be measured from the date the patient is enrolled in this study to death, due to any cause
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Oct 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606421
- Sponsor's protocol ID
- 18-5106
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2018
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel MRI Techniques Before and After Brain Radiotherapy With Parallel Assessments of Neurocognitive Function
- ClinicalTrials.gov ID
- NCT03606421
- Acronym / sponsor ID
- 18-5106
- Conditions
- Neurocognitive Dysfunction, Brain Metastases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Jul 2018 (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 study will be a dual-arm prospective longitudinal cohort study for patients with brain metastases, at least one of which is appropriate for radiotherapy, to explore brain and cognitive changes following SRS or WBRT and evaluate the feasibility of a novel MRI protocol to identify potential radiological biomarkers of NCF decline.
Patients diagnosed with brain mets will be assigned to either Arm A or Arm B, depending on their treatment plan. Patients in Arm A will be treated with SRS. Patients in Arm B will be treated with WBRT.
Patients' neurocognitive function will be assessed before their radiation treatment and followed up for 2 years post treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Radiation: SRS and neurocognitive assessmentsPatients in Arm A will be treated with stereotactic radiosurgery (SRS) which is a modern method of treating brain lesions that delivers a high amount of radiation to a small volume of the brain affected by a tumour; and is the standard of care for patients with a limited number of brain metastases. |
| Arm B. | – | Radiation: WBRT and neurocognitive assessmentsPatients in Arm B will be treated with whole brain radiotherapy, due to the number of lesions in their brain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain metastases, at least one of which is appropriate for radiotherapy
Key inclusion criteria (10 listed)
- Patients with brain metastases will be included in this study. Patients with known malignancies but without brain metastases, or patients with primary brain tumors are not eligible for enrollment.
- MRI confirmed 1-10 lesions. Each lesion must not be intended for resection.
- No prior radiation therapy for brain tumours.
- For patients enrolled to arm B, ability to tolerate RespirAct. Based on studies in patients with severe cerebrovascular disease, an 8 - 16% drop-out rate at the time of the first exposure to RespirAct CVR testing is expected [9]. The fourth generation of this device has been associated with increased tolerability secondary to elimination of a physical rebreathing circuit replaced by a digital re-breath analog. This improvement is expected to achieve a drop-out rate significantly below 10%.
- Patients must have a GPA greater than or equal to 1.0.
Key exclusion criteria (12 listed)
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
- Pregnant patients will be excluded from this study.
- Prior cranial radiotherapy
- Inability to complete MRI with contrast of the head, or a known allergy to gadolinium
- Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor.
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 |
|---|---|---|
| SRS and neurocognitive assessmentsPatients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires. | Radiation | Arm A |
| WBRT and neurocognitive assessmentsPatients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires. | Radiation | Arm B. |
Primary outcome
change in neurocognitive function (NCF)
Time frame: Over 24 months
To characterize change in NCF from baseline (pre-SRS treatment), to 24 months following using the NCF-A Battery
4 secondary outcomes
Symptomatic Radiation Toxicity
Time frame: 3-24 months
Local Failure
Time frame: up to 24 months
Distant Failure
Time frame: up to 24 months
Survival
Time frame: up to 24 months
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 11 Sep 2026.
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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 Neurocognitive Dysfunction and Brain Metastases, run by University Health Network, Toronto at 1 site in Canada.
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 10 inclusion and 12 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 11 Sep 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 Canada. 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 neurocognitive function (NCF) (time frame: Over 24 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 11 Sep 2026.