NCT06432660进行中（未招募）不适用
Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
Duke University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年7月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of participants with no disease recurrence within the radiation therapy field.
研究概览
简要总结
This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.
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
- 否
入选标准
- •Patients 18 years of age or older with unilateral primary choroidal melanoma
- •Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study)
- •Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)
- •Patients with best-corrected visual acuity in the fellow eye of 20/200 or better
- •Patients must be treated with IsoAid Eye Physics eye plaques
排除标准
- •Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.
- •Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible
- •Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
- •Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
- •Patients with extraocular disease
研究组 & 干预措施
Ocular Melanoma
Patients 18 years of age or older with unilateral primary choroidal melanoma
干预措施: Data collection (Other)
结局指标
主要结局
Percentage of participants with no disease recurrence within the radiation therapy field.
时间窗: 5 years
Number of disease free participants expressed as a percentage of the total number of participants enrolled
次要结局
未报告次要终点
研究者
研究点 (1)
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