7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 7t MRI.
- Who it may be relevant to
- Registry conditions: Small-cell Lung Cancer, Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 7t MRI
7t brain MRI followed by up to 12 months of standard of care 1.5t/3t MRI scans
Primary outcome measures
- 7t MRI Brain Metastases Detection [Time frame: 3, 6, 9, 12 months after 7T MRI]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of Missouri — Columbia
Identifiers
NCT: NCT07175077 · 2122797