Malignant Solid NeoplasmNCT06200116
Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning
An observational study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Dec 2024to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All employed medical dosimetrists or medical dosimetry assistants who routinely perform review of AI generated auto-segmentation of normal tissues.
Who may be able to join
- 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
Who cannot join
- Inability to complete study surveys
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Timothy F. Kozelsky, M.D.
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Zachary C. Wilson, M.D.
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Byron C. May, M.D.
- Recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Abigail L. Stockham, M.D.
- Recruiting
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ron S. Smith, M.D.
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Doug J. Moseley, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Carlos E. Vargas, M.D.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants complete surveys about the performance/functionality of the auto-segmentation algorithm on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start2 Dec 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doug J. Moseley, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200116
- Sponsor's protocol ID
- ROR2272
- Other IDs
- NCI-2023-10652, 22-004438
- Status last verified
- Jul 2026
- First submitted
- 28 Dec 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning
- ClinicalTrials.gov ID
- NCT06200116
- Acronym / sponsor ID
- ROR2272
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants complete surveys about the performance/functionality of the auto-segmentation algorithm on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All employed medical dosimetrists or medical dosimetry assistants who routinely perform review of AI generated auto-segmentation of normal tissues.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to complete study surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Proportion of success
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doug J. Moseley, PhD principal investigator
Mayo Clinic in Rochester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of success (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.