NCT04769960进行中（未招募）不适用
A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Safety of MRI scans for patients with breast tissue expanders
研究概览
简要总结
The purpose of this study is to find out whether it is safe to perform MRI scans in people who have breast tissue expanders in place.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Patients with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander. Breast tissue expanders marked as "MRI unsafe" will be allowed with exceptions as described in the Participant
排除标准
- •. While all types of MRI will be included in this study, including breast MRI, we anticipate that most of the MRI examinations ordered will evaluate the brain or spine for detecting or following metastasis.
- •Inclusion Criteria:
- •Patient ≥ 18 years old on day of signing informed consent
- •Has a breast tissue expander implanted > 28 days ago
- •Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander
- •Exclusion Criteria:
- •Patients with AeroForm Tissue Expanders (manufactured by AirXpanders)
- •Anyone who would normally be excluded from undergoing an MRI examination as per the Memorial Hospital for Cancer and Allied Diseases screening policy in the MRI Safety Policy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside from having a breast tissue expander
- •Patients who are reportedly pregnant, who have a positive urine or serum pregnancy test at the time of imaging, or for which pregnancy cannot be ruled out.
- •Patients who are unable to tolerate, comply or complete the MRI exam due to claustrophobia, anxiety, known psychiatric or substance abuse disorder, age, frailty, or medical instability.
结局指标
主要结局
Safety of MRI scans for patients with breast tissue expanders
时间窗: 2 years
Our first aim is to assess the safety of imaging patients with breast tissue expanders in the MRI. Among the 50 MRI scans, if we can successfully complete at least 50, meaning that there are no issues of burning, heating, or pain in the region of the breast tissue expander that prevents the completion of the MRI, then we will declare the imaging safe and worthy of further investigation.
次要结局
未报告次要终点
研究者
研究点 (5)
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