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Recruiting

NCT Number: NCT07827001

PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Aaron Simon, MD

CONTACT

[email protected]

1-877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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..

  4. 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..

Secondary outcomes

  1. Incidence of pre-defined safety events

    Time frame: 1 year

    Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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