NCT06409000

Brief Summary

This study evaluates if three dimensional (3D) surface images can be used instead of the standard computed tomography (CT) scans for treatment planning in electron radiation therapy. 3D scanning has previously been used by several groups to design patient-specific devices to be 3D printed, and as has shown excellent agreement with CT obtained surfaces. Using 3D surface imaging instead of x-ray based CT, benefits include: no ionizing radiation used to produce images, shorter time between patient consultation and treatment, and ability to produce and evaluate patient-specific devices for electron therapy earlier in the treatment planning process. This study may help researchers learn how 3D surface scanning may be used to produce a virtual CT image of patient surfaces, and accurately replace traditional planning CT for treatment planning of electron based radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

May 7, 2024

Last Update Submit

February 20, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dose distribution agreement between virtual and planning computed tomography (CT) datasets

    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

    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

    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

Study Arms (1)

Observational (3D surface scans, medical records)

Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.

Other: Electronic Health Record ReviewProcedure: Three-Dimensional Imaging

Interventions

Medical records reviewed

Observational (3D surface scans, medical records)

Undergo 3D surface scans

Also known as: 3-D Imaging, 3-Dimensional Imaging, 3D Imaging, Medical Imaging, Three Dimensional
Observational (3D surface scans, medical records)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being treated with electron radiation therapy at Mayo Clinic.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Interventions

Imaging, Three-Dimensional

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Daniel P. Harrington, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

January 19, 2021

Primary Completion

February 5, 2026

Study Completion

February 5, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations