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_TEST
    An MRI brain scan with and without gadolinium contrast. Three scans are planned for each participant.
  • Blood draws — OTHER
    Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
  • Quality of Life Questionnaires — OTHER
    Participants 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 — DRUG
    Given 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 Brain
    Brain 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

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Study Nurse
336-713-7748
Michael Farris, MD (PRINCIPAL_INVESTIGATOR)

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