Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MRI of the Brain
- Blood draws
- Quality of Life Questionnaires
- Gadolinium
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov