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NCT05692635 | Recruiting | Brain Metastases

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Sponsor:

Wake Forest University Health Sciences

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.

Condition or disease

Brain Metastases

Nonsmall Cell Lung Cancer Stage III

Intervention/treatment

MRI of the Brain

Blood draws

Quality of Life Questionnaires

Gadolinium

Phase

Phase 2

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}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : August 2025
Arm Intervention/treatment

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.

Diagnostic Test: MRI of the Brain

Other: Blood draws

Other: Quality of Life Questionnaires

Drug: Gadolinium
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Age ≥ 18 years of age.
  • Patients with non-squamous locally advanced lung cancer defined by American Joint Committee on Cancer (AJCC) version 8 stage IIIA, IIIB, or IIIC disease.
  • Histology described as adeno-squamous or not otherwise specified favoring squamous are eligible.
  • Patients may be enrolled before or after the start of radiation therapy but must be enrolled and have their first surveillance MRI brain at 120 +/- 10 days of their first treatment of radiation therapy for their locally advanced lung cancer. The first radiation treatment is defined as day 1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
  • Epidermal growth factor receptor (EGFR) > 30 mL/min/1.73m2.
  • Patients must be eligible for a brain MRI per the Wake Forest MRI safety screening checklist questionnaire. This will be completed by a MRI imaging technician, enrolling physician, CPDM staff member, a magnetic resonance safety officer, and/or a radiologist as indicated in the form.
Exclusion Criteria
  • Known brain metastases on staging MRI.
  • Questionable findings that may represent a differential of vasculature abnormalities/stroke/ and or metastatic disease with recommended short interval follow-up are not an exclusion factor for study participation. The recommended follow-up imaging for such findings should have no bearing on the imaging schedule in this protocol, and this research protocol imaging should NOT serve as an official follow-up scan for such findings.
  • Patients who are pregnant or breastfeeding.
  • Premenopausal persons of childbearing potential must have a negative pregnancy test within 14 days of enrollment. If women are not of childbearing potential as defined by women who are menopausal female or has had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure, they will not require a pregnancy test. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Locations

Recruiting

United States, North Carolina

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157