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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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 intervention
Before each MRI, participants will give about a teaspoon of blood to test for clinical purposes.
Quality of Life Questionnaires
Other intervention
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

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Surveillance MRI of the BrainExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in Central Nervous System Symptoms - Central Nervous System Symptom Scoring Form

Symptomatic brain metastasis presentation (yes or no) will be determined for each participant. Symptomatic brain metastasis presentation anytime during follow-up will be considered a YES. Asymptomatic presentation and death during follow-up without symptomatic presentation will be considered a NO. Patients with incomplete follow-up for reasons other than death will be excluded from the analysis. The proportion with symptomatic presentation will be calculated, and compared to the historical rate of 24% using a one-sample proportion test. A symptomatic brain metastasis presentation is defined as imaging demonstrating evidence of brain metastasis(es) and a change in any given central nervous system symptom. Questions require a YES or NO answer related to symptoms. Questions that are answered YES more often would indicate a unfavorable change in central nervous system symptoms

Time frame