7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)

University of Missouri (MU)

Status: Enrolling

Conditions: Brain Metastases; Small-cell Lung Cancer

Treatments: Device: 7t MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07175077

2122797

Details and patient eligibility

About

Comparison of a 7t MRI to standard of care 1.5t/3t MRI scans to determine if earlier detection of brain metastases are possible on a 7t.

Full description

This study is looking at patients diagnosed with small-cell lung cancer & have declined prophylactic cranial irradiation. Patients must have had a 1.5t/3t MRI performed within 4 weeks of consenting to the trial that was negative for brain metastases. Patients will then undergo a 7t MRI & be followed for their standard of care scans for 12 months or until confirmed metastases are detected. Once a patient has confirmed brain mets, their standard of care scans will be used for an analysis compared to the 7t scan to determine if earlier detection of brain micro metastases are feasible.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC). • Patient must have an MRI of the brain, performed within 4 weeks prior to consent, documenting no evidence of brain metastases or leptomeningeal disease.
• Patient also must not have a history of brain metastases or leptomeningeal disease.
• Patient must refuse PCI and agree to surveillance with brain MRI scans (1.5T/3T).
• Patient must be ≥ 18 years of age.
• Patient must have ECOG Performance Status of 0-2
• Patients must be able to tolerate the 7T MRI

Exclusion criteria

• Patient must not have a contraindication to an MRI, such as implanted metal devices or foreign bodies.
• Patient must not have a contraindication to gadolinium contrast administration during MR imaging.
• Patient must not have other metastatic malignancies requiring current active treatment.
• Pregnant patients are excluded. Pregnancy status will be confirmed verbally.