Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06200116
• Lead Sponsor: Mayo Clinic

Brief Summary

This study measures the utility of a novel artificial intelligence (AI) algorithm for performing auto-segmentation of computed tomography (CT) scans for radiation therapy planning.

Detailed Description

PRIMARY OBJECTIVE:

I. To measure the observed utility of an AI algorithm for normal segmentation by recording study subjects' observations of its function.

OUTLINE: This is an observational study.

Participants complete surveys about the performance/functionality of the auto-segmentation algorithm on study.

Study Timeline

• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Study First Posted: 2024-01-10
• Study Start: 2024-12-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Employment at Mayo Clinic Arizona, Florida, or Rochester (which includes Regional Practice sites located at Mayo Clinic Health System locations) as train clinical staff that participate in normal tissue segmentation

Exclusion Criteria

• Inability to complete study surveys

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Participants create and review output auto-segmentations of CT images using the AI algorithm and complete a survey about the performance/functionality of the auto segmentation algorithm on study.

Primary Outcome Measures

Name	Time	Method
Proportion of success	Baseline	Will be evaluated by question 1 of the end user survey, which evaluates the level of modification to the artificial intelligence generated auto-segmentation structures that was required (no modification, minor modification, or major modification). Auto-segmentation algorithm data will be collected through an electronic data collection form.

Trial Locations

Locations (7)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea; 🇺🇸 Albert Lea, Minnesota, United States

Mayo Clinic Health Systems-Mankato; 🇺🇸 Mankato, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire Clinic; 🇺🇸 Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States