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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07463833
Enrollment
207
Registered
2026-03-11
Start date
2026-06-22
Completion date
2027-07-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Prostate Cancer

Keywords

radiation therapy, artificial intelligence (AI), machine learning (ML), radiation therapy (RT), intensity-modulated radiation therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT), Image-guided radiation therapy (IGRT)

Brief summary

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

DEVICEThe 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 integrated into the existing clinical workflow. The system functions solely as a decision support aid and does not perform or initiate any autonomous treatment planning actions, dose delivery changes, or clinical interventions. During simulation (SIM) review, physician generated target and organ at risk contours are reviewed first, consistent with standard practice. Only after this initial review may the treating physician optionally access the AI generated contours for comparative purposes.

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTOlivia Morton
olivia_roberts@med.unc.edu(984) 974-8441
CONTACTVictoria Xu
victoria_xu@med.unc.edu(984) 974-8444
PRINCIPAL_INVESTIGATORLukasz Mazur, PhD

UNC Lineberger Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026