- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06409000
Evaluation of 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Develop and benchmark the necessary software to convert a 3D scan to a virtual CT.
II. Compare the spatial accuracy of virtual CTs from 3D scans to the planning CT.
III. Compare radiation treatment plans based on the virtual CTs from aim 2 to treatment plans based on the actual planning CTs.
OUTLINE: This is an observational study.
Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (18 years old or older)
- Capable of consent
- Receiving electron therapy and a planning CT scan
- Consent to two 3D surface scans of treatment area
Exclusion Criteria:
- Pediatric patients
- Mentally incapable of study consent
- Receiving electron radiation for a breast cancer boost
- Receiving electrons for total skin electron therapy
- Patients with epilepsy or other seizure disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (3D surface scans, medical records)
Patients undergo 3D surface scans on study.
Patient's medical records are also reviewed on study.
|
Medical records reviewed
Undergo 3D surface scans
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dose distribution agreement between virtual and planning computed tomography (CT) datasets
Time Frame: Up to 2 months
|
The various three dimensional (3D) scans and CTs of the phantoms will be qualitatively assessed for agreement and accuracy to determine best practice, but there will be no statistical significance tested for.
Will be conducted entirely on inanimate, plastic, anthropomorphic models (phantoms).
|
Up to 2 months
|
|
Geometric agreement between virtual and planning CT datasets
Time Frame: Up to 2 months
|
Will test for distance to agreement differences between 3D scans taken at different time points (consultation, simulation, and treatment).
|
Up to 2 months
|
|
Geometric agreement between 3D scans taken at different time points
Time Frame: Up to 2 months
|
Various dose metrics will be extracted from each of the three types of dose distribution: the ground truth CT based dose distribution, the 3D scan based virtual CT dose distributions, and the flat water phantom based dose distributions.
Paired statistical tests will be used for each metric to test for significant differences between the various methods used to calculate the dose distributions.
|
Up to 2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel P. Harrington, MS, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-012790 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2022-09578 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ROA1971 (Other Identifier: Mayo Clinic Radiation Oncology)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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