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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Carlos E. Vargas, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Byron C. May, M.D.
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Recruiting
      • Mayo Clinic Health System in Albert Lea
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Timothy F. Kozelsky, M.D.
    • Mankato, Minnesota, United States, 56001
      • Recruiting
      • Mayo Clinic Health Systems-Mankato
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Ron S. Smith, M.D.
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Doug J. Moseley, PhD
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Recruiting
      • Mayo Clinic Health System-Eau Claire Clinic
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Zachary C. Wilson, M.D.
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Mayo Clinic Health System-Franciscan Healthcare
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Abigail L. Stockham, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All employed medical dosimetrists or medical dosimetry assistants who routinely perform review of AI generated auto-segmentation of normal tissues.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Participants complete surveys about the performance/functionality of the auto-segmentation algorithm on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of success	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.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Doug J. Moseley, PhD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ROR2272 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-10652 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 22-004438 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No