204 Participants Needed

Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Vs Standard Radiation Treatment Planning

Recruiting at 5 trial locations
CT
CT
Overseen ByChristy Todd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.

Research Team

DJ

Daniel J. Ma, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

Inclusion Criteria

You are being treated with curative intent intensity modulated radiotherapy for head and neck cancer by a MD.
You must give written permission or have a legal representative grant consent on your behalf.
You are committed to revisiting the school for additional research.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Planning

Participants undergo treatment planning with either Standard of Care or Machine Learning Assisted Planning

Up to 30 days
1 visit (in-person)

Radiation Treatment

Participants receive radiation treatment as per the assigned planning method

6 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person)

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Standard of care (SOC) treatment planningExperimental Treatment1 Intervention
Patients randomized to the SOC treatment planning arm will receive a treatment planning computed tomography (CT) scan followed by dosimetric planning with a medical dosimetrist; and the plan will be reviewed by a medical physicist and radiation oncologist. This is the current standard practice for all radiation oncology patients.
Group II: Arm B: Machine Learning Assisted Planning (MLAP)Active Control1 Intervention
Patients randomized to the MLAP arm will receive a treatment planning scan followed by MLAP through the RapidPlan module produced by Varian. Of note, RapidPlan is an FDA cleared module with treatment planning being the approved usage for the program. The RapidPlan module has site specific treatment packages for different disease sites. These separate disease specific packages have different capabilities. For example, the Head and Neck package currently audits dosimetrist-generated plans for possible improvements. The MLAP arm of the trial will leverage the RapidPlan module's full capabilities upwards to the FDA-approved usage.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
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Recruited
3,221,000+
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