Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT05692635
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Brain Metastases
- Nonsmall Cell Lung Cancer Stage III
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MRI of the Brain — DIAGNOSTIC_TESTAn MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
- Blood draws — OTHERBefore each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
- Quality of Life Questionnaires — OTHERParticipants will fill out two questionnaires about their health. These questionnaires will tell investigators about any symptoms participants may be having that might be related to cancer spreading to their brain. This will take about 10-15 minutes to complete.
- Gadolinium — DRUGGiven intravenously
Study Details
The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.
Key Dates
- Start date
- Aug 30, 2023
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Surveillance MRI of the BrainBrain MRI will be performed as scheduled for up to 14 months or until detection of a brain metastasis, whichever occurs first.
Primary Outcome Measure
Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form [ Time Frame: At 4 months, 8 months, 14 months, 20 months and 26 months after first radiation therapy treatment ]
Central Contacts
- Study Coordinator336-713-0901
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | Study Nurse 336-713-7748 Michael Farris, MD (PRINCIPAL_INVESTIGATOR) |
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