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Recruiting NCT07463833

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

No phase Interventional Cancer Prostate Cancer

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: The Artificial Intelligence (AI)/ Machine Learning (ML) contribution to treatment planning.
Who it may be relevant to
Registry conditions: Cancer, Prostate Cancer. 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 →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device The Artificial Intelligence (AI)/ Machine Learning (ML) contribution to treatment planning
    All treatment planning and clinical monitoring are conducted in accordance with institutional standards and established departmental policies. Peer review activities proceed as they would in routine clinical practice, with the addition of optional Artificial Intelligence (AI) generated analytics available for clinician review. AI / Machine Learning (ML) system is embedded in scheduled departmental peer review meetings and presents analytic summaries and visualizations through a dashboard that is

Primary outcome measures

  • Percentage of patients with changes nodal volume contours [Time frame: Baseline]

Eligibility criteria

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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill

Identifiers

NCT: NCT07463833 · LCCC2607

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗