Small-cell Lung Cancer, Brain Metastases
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICE7t MRI
7t brain MRI followed by up to 12 months of standard of care 1.5t/3t MRI scans
Sponsors
Siemens Medical Solutions
University of Missouri-Columbia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7t MRI Brain Metastases Detection | 3, 6, 9, 12 months after 7T MRI | Comparison of 7t MRI to 1.5t/3t to determine if the 7t MRI was able to detect metastases prior to a 1.5t/3t MRI |
Countries
United States
Contacts
Primary ContactBrooke McDaniel
Outcome results
None listed