Can doctors watch brain metastases instead of zapping them?
NCT ID NCT07827001
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers at the University of California, Irvine are testing whether patients with brain metastases can safely skip immediate surgery or radiation and instead have their tumors monitored with regular imaging, cognitive tests, and quality-of-life questionnaires. All participants receive systemic therapy that penetrates the central nervous system. The trial enrolls 12 adults with metastatic cancer that has spread to the brain and measures whether patients can be enrolled, complete surveillance scans, and finish the assessments. It also tracks safety events linked to brain tumor growth during systemic treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an active surveillance approach that monitors brain metastases with imaging, cognitive tests, and quality-of-life questionnaires instead of immediate surgery or radiation
- What this could lead to
- If it works, this could offer a way to delay or avoid surgery and radiation for brain metastases while systemic therapy does its job, sparing patients the side effects of local treatment.
- What could go wrong
- This is a small pilot study with 12 patients, so it cannot prove that surveillance is as safe as immediate local therapy. Brain metastases may grow during monitoring, and the trial tracks those safety events rather than preventing them.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with brain metastases undergoing CNS-penetrating systemic therapy
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center, University of California, Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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