Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT05692635
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Primary Objective: To evaluate whether additional follow up brain MRI in patients with non-squamous stage III nonsmall cell lung cancer who were previously treated with curative intent radiation therapy reduces the rate of symptomatic brain metastasis presentation as compared to historical controls.
Secondary Objectives:
* To estimate time to brain failure in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
* To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
OUTLINE:
Patients undergo MRI with or without gadolinium contrast intravenously (IV) as well as blood sample collection on study.
Patients are followed for approximately 780 days from the first treatment of radiation or until death, whichever occurs first
Secondary Objectives:
* To estimate time to brain failure in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
* To describe documented brain metastasis(es) characteristics in patients with non-squamous stage III nonsmall cell lung cancer previously treated with curative intent radiation therapy who undergo additional surveillance brain magnetic resonance imaging.
OUTLINE:
Patients undergo MRI with or without gadolinium contrast intravenously (IV) as well as blood sample collection on study.
Patients are followed for approximately 780 days from the first treatment of radiation or until death, whichever occurs first
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WFBCCC 99522 | OTHER | Wake Forest Baptist Comprehensive Cancer Center | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |