Tumor, SolidNCT04095091
Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
An observational study of Tumor, Solid, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- 4D Planar US Transducer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 4 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited from the general population. Patients will be recruited from clinics that serve this patient population.
Who may be able to join
- Must be eighteen (18) years of age or older.
- Must be able to provide informed consent.
- Patients diagnosed with malignancies of the liver.
Who cannot join
- Under the age of eighteen (18) years.
- BMI exceeds the size of the bore of the MRI scanner.
- Unable or unwilling to provide informed consent.
- Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.
- Women who are pregnant, suspect they might be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53704
About this study
The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. The secondary objective of this study is to determine if several salient features identified in the US scan can be used to predict target motion identified in the MR scan.
Read the detailed description
The goal of radiotherapy treatment of cancer is to cure or locally control the disease while minimizing complications to healthy tissue. Given the complexity of tumor and normal tissue response to radiation, precise and accurate delivery of absorbed dose distributions, within known tolerances, is necessary to achieve the maximum therapeutic ratio. The complex treatment process of radiotherapy introduces geometrical uncertainties including respiratory induced tumor motion. The goal of this research is to develop and validate a novel image-guidance technique to directly track tumor motion using a 4-dimensional (4D) planar ultrasound (US) transducer during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition. The image sets will be rapidly matched using advanced image and signal processing algorithms, allowing the display of virtual MR images of the tumor/organ motion in real-time from an ultrasound acquisition.
- Conditions
- Tumor, Solid
- Being tested
- 4D Planar US Transducer
- Keywords
- Radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D Planar US TransducerDevice
Also called 4D US
This 4D planar US transducer is being developed and validated to provide a novel image-guidance technique to directly track tumor motion during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy volunteers will be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan.
A substudy including patients undergoing radiotherapy for malignancies of the abdomen and pelvis. They will also be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan. Receives: Device: 4D Planar US Transducer | |
| Patient Group | Patients receiving radiotherapy for malignancies of the abdomen and pelvis will be asked to complete two research visits lasting approximately one hour. Each visit will include a 30 minute combined 4D ultrasound and 4D MRI scan. Receives: Device: 4D Planar US Transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility testing
To conduct non-contrast agent MR and ultrasound scans in order to evaluate and demonstrate, on a continuing basis, the technical and clinical feasibility of new or modified features (the "Prototype") of a combined MRI and ultrasound system, and software. Prototype MRI and ultrasound systems are defined as components of the MRI system (software) and ultrasound system (hardware and software) that have been modified in some form.
Measured: 12 Months
MR/US Motion Management Platform
The goal of this trial is to assess the feasibility of implementing the system into clinical practice and to compare the dosimetric advantages of its use. In a retrospective analysis, the patients' standard treatment plan with international target volume (ITV) expansion will be directly compared with a second treatment plan using a smaller respiratory-gated margin (i.e., gross tumor volume (GTV)-only expanded for planning target volume (PTV) without ITV expansion). Normal tissue constraints will be specified and follow standard clinical constraints. The percent of liver volume receiving greater than 18 Gy will be used as a quantitative metric to assess the dosimetric impact of our platform. In addition, overall treatment time with the relative "beam on time" and duty cycle will also be compared. Additionally, the ultrasound acquisition during treatment will be used to assess intra- and interfraction changes in breathing patterns as the patients progress through treatment.
Measured: 12 Months
Secondary outcomes (2)
Accuracy of image-guidance technique
The accuracy of our image-guidance technique will be done by showing that several salient features identified in the US scan can be used to predict/model target motion identified in the MR scan. In this context the target will be a large easily identifiable structure in the test subject (e.g. cyst, vessel). MRI and ultrasound images will be acquired simultaneously such that the motion of tissues or organs in the body can be effectively tracked as a function of respiratory state in the subject. In this manner, the ultrasound system will allow real-time tracking of salient features in the patient that are indicative of the respiratory state.
Measured: 12 Months
Test/re-test
A secondary objective of this substudy is to evaluate the accuracy of probe re-position during subsequent treatment sessions (i.e. test/re-test) in cancer patient subjects. The probe will be positioned during one of the patient subjects and images will be acquired. During a subsequent treatment session the probe will be re-positioned and images will be acquired. The image data will be used to evaluate to measure the concordance between the two datasets.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start14 Sep 2017
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Why it stopped: Device to be used in study is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bryan Bednarz, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095091
- Sponsor's protocol ID
- 2017-0684
- Other IDs
- R01CA190298-01A1, A534800, SMPH\MEDICAL PHYSICS, Protocol Version 5/27/2021
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2019
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
- ClinicalTrials.gov ID
- NCT04095091
- Acronym / sponsor ID
- 2017-0684
- Conditions
- Tumor, Solid
- Keywords
- Radiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device to be used in study is no longer available
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 19 Sep 2019 (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.
The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. The secondary objective of this study is to determine if several salient features identified in the US scan can be used to predict target motion identified in the MR scan.
Detailed description
The goal of radiotherapy treatment of cancer is to cure or locally control the disease while minimizing complications to healthy tissue. Given the complexity of tumor and normal tissue response to radiation, precise and accurate delivery of absorbed dose distributions, within known tolerances, is necessary to achieve the maximum therapeutic ratio. The complex treatment process of radiotherapy introduces geometrical uncertainties including respiratory induced tumor motion. The goal of this research is to develop and validate a novel image-guidance technique to directly track tumor motion using a 4-dimensional (4D) planar ultrasound (US) transducer during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition. The image sets will be rapidly matched using advanced image and signal processing algorithms, allowing the display of virtual MR images of the tumor/organ motion in real-time from an ultrasound acquisition.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Device: 4D Planar US TransducerHealthy volunteers will be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan. A substudy including patients undergoing radiotherapy for malignancies of the abdomen and pelvis. They will also be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan. |
| Patient Group | – | Device: 4D Planar US TransducerPatients receiving radiotherapy for malignancies of the abdomen and pelvis will be asked to complete two research visits lasting approximately one hour. Each visit will include a 30 minute combined 4D ultrasound and 4D MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited from the general population. Patients will be recruited from clinics that serve this patient population.
Key inclusion criteria (3 listed)
- Must be eighteen (18) years of age or older.
- Must be able to provide informed consent.
- Patients diagnosed with malignancies of the liver.
Key exclusion criteria (5 listed)
- Under the age of eighteen (18) years.
- BMI exceeds the size of the bore of the MRI scanner.
- Unable or unwilling to provide informed consent.
- Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.
- Women who are pregnant, suspect they might be pregnant or breastfeeding.
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 |
|---|---|---|
| 4D Planar US TransducerAlso: 4D USThis 4D planar US transducer is being developed and validated to provide a novel image-guidance technique to directly track tumor motion during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition. | Device | Control Group, Patient Group |
Primary outcome
Feasibility testing
Time frame: 12 Months
To conduct non-contrast agent MR and ultrasound scans in order to evaluate and demonstrate, on a continuing basis, the technical and clinical feasibility of new or modified features (the "Prototype") of a combined MRI and ultrasound system, and software. Prototype MRI and ultrasound systems are defined as components of the MRI system (software) and ultrasound system (hardware and software) that have been modified in some form.
MR/US Motion Management Platform
Time frame: 12 Months
The goal of this trial is to assess the feasibility of implementing the system into clinical practice and to compare the dosimetric advantages of its use. In a retrospective analysis, the patients' standard treatment plan with international target volume (ITV) expansion will be directly compared with a second treatment plan using a smaller respiratory-gated margin (i.e., gross tumor volume (GTV)-only expanded for planning target volume (PTV) without ITV expansion). Normal tissue constraints will be specified and follow standard clinical constraints. The percent of liver volume receiving greater than 18 Gy will be used as a quantitative metric to assess the dosimetric impact of our platform. In addition, overall treatment time with the relative "beam on time" and duty cycle will also be compared. Additionally, the ultrasound acquisition during treatment will be used to assess intra- and interfraction changes in breathing patterns as the patients progress through treatment.
2 secondary outcomes
Accuracy of image-guidance technique
Time frame: 12 Months
Test/re-test
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Device to be used in study is no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
Bryan Bednarz, PhD principal investigator
University of Wisconsin, Madison
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 Tumor, Solid, run by University of Wisconsin, Madison 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 3 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: stopped early, as of the sponsor's last update on 31 Oct 2023. 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 was stopped early (reason given: Device to be used in study is no longer available). Results are not available in the source record.
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?
Feasibility testing (time frame: 12 Months). The study lists 2 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 31 Oct 2023.