跳至主要内容
临床试验/NCT07463833
NCT07463833招募中不适用

Development and Assessment of Artificial Intelligence (AI)-Enhanced Pretreatment Peer-review Process to Improve Patient Safety in Radiation Oncology

UNC Lineberger Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2026年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
207
试验地点
1
主要终点
Percentage of patients with changes nodal volume contours

研究概览

简要总结

This prospective study will test artificial intelligence (AI) and machine learning (ML) decision support tools. This tool is designed to help doctors, physicists and other staff during pre-treatment peer review, a step where treatment plans are checked before a patient begins care.

The system highlights summaries showing how different providers may vary in their treatment planning (provider-variability summaries) and points out the best signals or warning signs to look for (optimal cues). By drawing attention to these patterns and cues, the tool aims to help reviewers spot possible treatment-planning mistakes earlier, reduce the chance of errors, and improve overall patient safety.

详细描述

As radiation therapy (RT) becomes more complex, the number of possible error pathways increases. AI-supported peer review can help catch errors that might otherwise go unnoticed and promote consistent, equitable safety standards across both rural and urban clinics.

Radiation therapy (RT) is used in about 50% of cancer patients and usually given in outpatient clinics. Newer technologies such as intensity-modulated radiation therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT), and Image-guided radiation therapy (IGRT), improve treatment by better protecting normal tissue and higher dose in target areas. However, they are more complex and require very precise definition of tumor targets and normal tissues. Even small errors in outlining these areas can lead to under-treating the tumor or over-treating healthy tissue. Studies show that errors in defining target areas have increased in modern radiation oncology. Because these treatments are more cognitively demanding, the risk of planning errors has increased and, in some cases, errors can cause serious harm.

Pre-treatment peer review is where a multidisciplinary team reviews the treatment plan before therapy begins is an important safety step and is strongly recommended. It is most effective when done before treatment starts, since making corrections later can cause treatment delays, rushed changes, and added The potential impact on patient safety is substantial.

Because of the growing complexity and workload, there is a need to strengthen and partially automate pre-treatment peer review. AI/ML decision-support tools can help by summarizing key information, highlighting unusual plan features, and drawing attention to areas of potential risk. These tools do not make treatment decisions. Instead, they provide analytics and visual summaries to support clinicians and reduce cognitive burden.

Because the tool also highlights differences in how providers plan treatments, it may help identify variation in care and bring attention to potential health disparities, supporting future efforts to improve equity in radiation oncology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
  • Inclusion Criteria:
  • Providers only
  • ≥18 years
  • Peer-review attendees at participating clinics
  • Patients only
  • ≥18 years
  • All patients with prostate cancer radiation therapy cases treated at participating sites (no intervention delivered to patients)

排除标准

  • Providers only
  • Providers unwilling/unable to comply with study procedures; sites unable to implement the workflow or provide required outcomes.
  • Patients and Providers
  • Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent

研究组 & 干预措施

Patients

No Intervention

Prostate cancer patients who receive radiation therapy contribute de-identified safety outcomes.

Providers

Other

Radiation oncology providers engaged in peer-review at participating clinics.

干预措施: The Artificial Intelligence (AI)/ Machine Learning (ML) contribution to treatment planning (Device)

结局指标

主要结局

Percentage of patients with changes nodal volume contours

时间窗: Baseline

Percentage of patients with documented changes regarding nodal volume contours after Artificial Intelligence (AI) enhanced peer review.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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