Monitoring the brain with MRI to detect cancer spread early
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance in Non-Squamous Locally Advanced Non-Small Cell Lung Cancer
This study is testing if regular brain MRI scans after radiation therapy can help catch cancer spread in patients with advanced lung cancer before they start showing symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05692635 on ClinicalTrials.gov |
What this trial studies
This research aims to determine if regular brain MRI surveillance after radiation therapy can help identify brain metastases in patients with non-squamous stage III nonsmall cell lung cancer before they become symptomatic. The primary objective is to compare the rate of symptomatic brain metastasis presentation in patients undergoing additional MRI follow-ups to historical controls. Secondary objectives include estimating the time to brain failure and documenting the characteristics of brain metastases in these patients. Participants will undergo MRI scans and blood sample collection, with follow-up lasting approximately 780 days.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-squamous locally advanced lung cancer who have received curative intent radiation therapy.
Not a fit: Patients with non-locally advanced lung cancer or those who are not eligible for MRI surveillance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and treatment of brain metastases, potentially improving patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific method of using MRI surveillance post-radiation in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Michael Farris, MD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Study Coordinator
- Email: Jada.Kluttz@wakehealth.edu
- Phone: 336-713-0901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.