Clinical trial · Observational
PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe
A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy
NCT07827001CI-TRIAL-00126434recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Cancer Metastatic | — | UNRESOLVED | — |
| CNS Cancer | Malignant Central Nervous System Neoplasm | ALIAS | 0.90 |
| Nervous System Cancer | Malignant Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- SingleArm
- description
- CNS-Penetrating Systemic Therapy
Primary outcomes (4)
- measure
- Feasibility of Enrolling Patients
- timeFrame
- 1 year
- description
- Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
- measure
- Feasibility of completing required surveillance imaging
- timeFrame
- 1 year
- description
- Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
- measure
- Feasibility of administering Cognitive Assessments
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.