7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 7t MRI Brain Metastases Detection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
7t MRI Brain Metastases Detection
时间窗: 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
次要结局
未报告次要终点
研究者
Bo Lu
CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY
University of Missouri-Columbia