ClinicalTrials.gg
RecruitingNCT07827001Updated Sep 18, 2026

PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe

An observational study in Brain Cancer, Brain Cancer Metastatic and Nervous System Cancer, sponsored by University of California, Irvine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by University of California, Irvine · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,443 studies in Brain Neoplasms with a site in United States — 229 open to participants now, 352 under way, 18 of them phase 3. Brain Neoplasms · United States.

Planned enrollment
159th of 191
12 · median 76
Started
2026
with 52 others
Observational
193 of 1,443
36 open now
Primary completion
2028-08
later than 257 of 350 live
Registered
1,437th of 1,443
by date

Among the 1,443 studies in Brain Neoplasms with a site in United States, this one is the 159th largest by planned enrollment of the 191 observational ones that give a count, is one of 53 that started in 2026, is one of 193 observational ones, reaches primary completion later than 257 of the 350 other live ones, and was the 1,437th registered.

Brain Neoplasms

2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.

Browse Brain Neoplasms studies →

Open to participants now

229 of the 1,443 studies in Brain Neoplasms with a site in United States are open now. Recruiting first, the newest first:

223 more — sign in →

All 229 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 423 Brain Neoplasms studies recruiting now, 284 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,443 studies in Brain Neoplasms with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Brain Cancer
  • Brain Cancer Metastatic
  • Nervous System Cancer
  • CNS Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with brain metastases undergoing CNS-penetrating systemic therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have or cytologically confirmed non-hematologic .
  • Patients must have at least one new or progressive that has not received prior local therapy (surgery or radiation therapy).
  • Patients must have no active brain metastasis >3cm in size.
  • is permitted
  • Patients with only non- 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 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 and FACT-BR assessments (refer to section 4.4.1).
  • Performance status: performance status ≥50%.
  • of ≥3 months.
  • Ability to understand and willingness to sign a written document.

Exclusion criteria

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 .
  • Patients requiring , anticonvulsants, or other palliative medications related to brain metastases.
  • Patients with conditions that exclude them from undergoing magnetic resonance imaging.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
12 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • SingleArm

    CNS-Penetrating Systemic Therapy

06

What researchers measure

Primary outcomes

  1. Feasibility of Enrolling Patients

    Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.

    Time frame: 1 year

  2. Feasibility of completing required surveillance imaging

    Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.

    Time frame: 1 year

  3. Feasibility of administering Cognitive Assessments

    Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..

    Time frame: 1 year

  4. 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..

    Time frame: 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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will only be shared as a condition for publication of study results in ICMJE journals

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2028, 24 months after the start.

Of 181 non-industry observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 269. This study's planned 24 months is below that.

Counting every sponsor, half of 199 studies reached it within 82 months; a quarter within 41 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 18, 2026
StartActual
Aug 4, 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2028
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07827001
Responsible party
Aaron Benjamin Simon (Asst Prof, University of California, Irvine) — Principal investigator
First posted
Sep 18, 2026
Start date
Aug 4, 2026
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Chao Family Comprehensive Cancer Center University of California, Irvine
Contact
ucstudy@uci.edu
1-877-827-8839
University of California Irvine Medical
Contact
Aaron Simon, MD
principal investigator · Chao Family Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion