Brain CancerNCT07827001
PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe
An observational study of Brain Cancer and Brain Cancer Metastatic, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Brain Cancer Metastatic, Nervous System Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to Aug 2028
- How long will I take part?
- 6 Months
- 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 undergoing CNS-penetrating systemic therapy
Who may be able to join
- Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
- Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
- Patients must have no active brain metastasis >3cm in size.
- Leptomeningeal disease is permitted
- Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
- Patients must have no symptoms attributable to active brain metastases.
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- At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
- Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
- Must be age ≥ 18 years.
- Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
- Performance status: KPS performance status ≥50%.
- Life expectancy of ≥3 months.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
- Patients with active symptomatic brain metastases.
- Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
- Patients with conditions that exclude them from undergoing magnetic resonance imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Aaron Simon, MD, 1-877-827-8839, ucstudy@uci.edu
About this study
Official title: A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy
This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.
- Medical subject headings
- Brain Neoplasms, Nervous System Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SingleArm | CNS-Penetrating Systemic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrolling Patients
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
Measured: 1 year
Feasibility of completing required surveillance imaging
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
Measured: 1 year
Feasibility of administering Cognitive Assessments
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Measured: 1 year
Feasibility of administering QOL Questionnaires
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Measured: 1 year
Secondary outcomes (1)
Incidence of pre-defined safety events
Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start4 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Benjamin Simon, University of California, Irvine
- Investigators
- Aaron Simon, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827001
- Sponsor's protocol ID
- STUDY00001311
- Other IDs
- UCI 25-197
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared as a condition for publication of study results in ICMJE journals
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy
- ClinicalTrials.gov ID
- NCT07827001
- Acronym / sponsor ID
- STUDY00001311
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Sep 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 is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SingleArm | – | –CNS-Penetrating Systemic Therapy |
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 undergoing CNS-penetrating systemic therapy
Key inclusion criteria (13 listed)
- Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
- Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
- Patients must have no active brain metastasis >3cm in size.
- Leptomeningeal disease is permitted
- Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
Key exclusion criteria (4 listed)
- Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
- Patients with active symptomatic brain metastases.
- Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
- Patients with conditions that exclude them from undergoing magnetic resonance imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Enrolling Patients
Time frame: 1 year
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
Feasibility of completing required surveillance imaging
Time frame: 1 year
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
Feasibility of administering Cognitive Assessments
Time frame: 1 year
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
Feasibility of administering QOL Questionnaires
Time frame: 1 year
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
1 secondary outcome
Incidence of pre-defined safety events
Time frame: 1 year
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 Sep 2026.
- Individual participant dataSharing planned: No. IPD will only be shared as a condition for publication of study results in ICMJE journals
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Aaron Simon, MD principal investigator
Chao Family Comprehensive Cancer Center
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 Brain Cancer and Brain Cancer Metastatic, run by University of California, Irvine at 1 site in United States.
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 13 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: looking for participants now, as of the sponsor's last update on 18 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 United States. 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 Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrolling Patients (time frame: 1 year). The study lists 4 primary outcomes in all. 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 18 Sep 2026.