Hematopoietic and Lymphatic System NeoplasmNCT06409000
Evaluation of 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Electronic Health Record Review and Three-Dimensional Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 5 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated with electron radiation therapy at Mayo Clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Electronic Health Record Review, Three-Dimensional Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical records reviewed
Three-Dimensional ImagingProcedure or surgery
Also called 3-D Imaging, 3-Dimensional Imaging, 3D Imaging, Medical Imaging, Three Dimensional
Undergo 3D surface scans
| Study group | Role | What they receive |
|---|---|---|
| Observational (3D surface scans, medical records) | Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study. Receives: Other: Electronic Health Record Review; Procedure: Three-Dimensional Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start19 Jan 2021
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System 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
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel P. Harrington, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409000
- Sponsor's protocol ID
- 19-012790
- Other IDs
- NCI-2022-09578, ROA1971, 19-012790
- Status last verified
- Feb 2026
- First submitted
- 7 May 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning
- ClinicalTrials.gov ID
- NCT06409000
- Acronym / sponsor ID
- 19-012790
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 10 May 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 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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (3D surface scans, medical records) | – | Other: Electronic Health Record Review, Procedure: Three-Dimensional ImagingPatients undergo 3D surface scans on study. Patient's medical records are also reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated with electron radiation therapy at Mayo Clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Electronic Health Record ReviewMedical records reviewed | Other | Observational (3D surface scans, medical records) |
| Three-Dimensional ImagingAlso: 3-D Imaging, 3-Dimensional Imaging, 3D Imaging, Medical Imaging, Three DimensionalUndergo 3D surface scans | Procedure or surgery | Observational (3D surface scans, medical records) |
Primary outcome
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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. This study is not recruiting at the moment.
Daniel P. Harrington, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose distribution agreement between virtual and planning computed tomography (CT) datasets (time frame: Up to 2 months). The study lists 3 primary outcomes in all. 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 24 Feb 2026.