CancerPhase 1NCT02331381
Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
A Phase 1 study testing Magnetic resonance imaging in people with Cancer and Malignant Tumor, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The results of this imaging and treatment planning protocol will aid in developing procedures for patient localization and future clinical implementation of low-field MRI to confirm positioning prior to radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignant Tumor
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2013to 7 Sep 2016
- Phase
- Phase 1
- 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
Eligibility Criteria:
- Scheduled to receive radiation therapy.
- At least 18 years of age.
- Does not meet any standard contraindications for MRI (such as being claustrophobic, having metal objects within the body that cannot be removed or having large tattoos), confirmed by completion of our clinical MRI questionnaire form
- Able to understand and willing to sign an IRB approved written informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Study of Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
The results of this imaging and treatment planning protocol will aid in developing procedures for patient localization and future clinical implementation of low-field MRI to confirm positioning prior to radiation treatment. Images acquired during this study may aid future study design for adaptive planning based on low-field MRI images. Moreover, results of this imaging and treatment planning may lead to guidance on optimal use of this novel device.
Read the detailed description
Recently, Viewray Inc (Cleveland, OH) has released the RenaissanceTM System 1000, which consists of the combination of an open, split solenoid 0.35 T MRI scanner that is equipped for parallel imaging with a 60Co gamma-ray radiation treatment unit. The MRI scanner is required to be a low field unit to allow for imaging with spatial integrity by limiting magnetic susceptibility artifacts due to the patient and to prevent significant perturbations of the dose distribution. The 0.35 T magnet is a variant of the Siemens MAGNETOM product used for intraoperative imaging.
A previous study of pilot imaging using this device without the 60Co sources was completed in 2012 (HRPO# 201105295). In this study, a total of 26 patients were imaged with the device. Fourteen of these patients also had onboard CT imaging (OB-CT) where the two sets of imaging and relative organs at risk (OARs) could be compared. Fifteen to 24 OARs were evaluated per anatomical site. In total, 221 OARs and 10 target structures were compared for visualization on MRI and OB-CT image sets by each physician. At least 2/3 physicians evaluated MRI as offering better visualization for 71% of structures, OB-CT offering better visualization for 10% of structures, and both offering equivalent visualization for 14% of structures. Physicians agreed unanimously for 74% and in majority for >99% of structures evaluated, respectively. For <1% of structures, no consensus was reached. Targets were better visualized on MRI in 4/10 cases, and were never better visualized on OB-CT images.
There were limitations to this prior study. The patients were not imaged in immobilization devices that are commonly used in radiation therapy. This precluded the creation of a mock radiation therapy plan using the device for these patients. Also, the device was not evaluated in the context of radiation therapy decision making, such as patient shifts, target localization and patient repositioning.
The purpose of this study is to evaluate the imaging and plan workflow for radiation therapy utilizing this novel device. For this protocol, only the MRI scanner of the machine will be utilized. The 60Co portion of the machine capable of radiation treatment administration will not be utilized, and there will be no experimental treatments or modifications to each patient's standard of care radiation treatment plan.
- Conditions
- Cancer, Malignant Tumor
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDevice
Also called MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Participants will have a custom immobilization device created for them for the purpose of the study. They will be scanned from one to four occasions during radiation treatment. If enrolled in the study prior to the first radiation treatment, the first imaging scan may be scheduled prior to the first radiation treatment, with subsequent scans during treatment separated by at least one day. Patients will be in the scanner for approximately 30 minutes to one hour, either prior to or following their standard of care radiotherapy treatment. Receives: Device: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of the radiation therapy plan
The radiation plan will be evaluated based on the recorded clinical goals prescribed by the attending physician. Plans will be classified as 'adequate' if they meet the prescribed goals for the clinical radiation therapy plan.
Measured: Duration of radiation therapy
Feasibility of patient localization workflow
The localization time will be classified as 'adequate' if it is less than or equal to 15 minutes.
Measured: Duration of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start26 Dec 2013
- Primary completion23 Dec 2015
- Study completion7 Sep 2016
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Michalski, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331381
- Sponsor's protocol ID
- 201311081
- Status last verified
- Feb 2017
- First submitted
- 2 Jan 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
- ClinicalTrials.gov ID
- NCT02331381
- Acronym / sponsor ID
- 201311081
- Conditions
- Cancer, Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 26 Dec 2013 (actual)
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 6 Jan 2015 (estimated)
- 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 results of this imaging and treatment planning protocol will aid in developing procedures for patient localization and future clinical implementation of low-field MRI to confirm positioning prior to radiation treatment. Images acquired during this study may aid future study design for adaptive planning based on low-field MRI images. Moreover, results of this imaging and treatment planning may lead to guidance on optimal use of this novel device.
Detailed description
Recently, Viewray Inc (Cleveland, OH) has released the RenaissanceTM System 1000, which consists of the combination of an open, split solenoid 0.35 T MRI scanner that is equipped for parallel imaging with a 60Co gamma-ray radiation treatment unit. The MRI scanner is required to be a low field unit to allow for imaging with spatial integrity by limiting magnetic susceptibility artifacts due to the patient and to prevent significant perturbations of the dose distribution. The 0.35 T magnet is a variant of the Siemens MAGNETOM product used for intraoperative imaging.
A previous study of pilot imaging using this device without the 60Co sources was completed in 2012 (HRPO# 201105295). In this study, a total of 26 patients were imaged with the device. Fourteen of these patients also had onboard CT imaging (OB-CT) where the two sets of imaging and relative organs at risk (OARs) could be compared. Fifteen to 24 OARs were evaluated per anatomical site. In total, 221 OARs and 10 target structures were compared for visualization on MRI and OB-CT image sets by each physician. At least 2/3 physicians evaluated MRI as offering better visualization for 71% of structures, OB-CT offering better visualization for 10% of structures, and both offering equivalent visualization for 14% of structures. Physicians agreed unanimously for 74% and in majority for >99% of structures evaluated, respectively. For <1% of structures, no consensus was reached. Targets were better visualized on MRI in 4/10 cases, and were never better visualized on OB-CT images.
There were limitations to this prior study. The patients were not imaged in immobilization devices that are commonly used in radiation therapy. This precluded the creation of a mock radiation therapy plan using the device for these patients. Also, the device was not evaluated in the context of radiation therapy decision making, such as patient shifts, target localization and patient repositioning.
The purpose of this study is to evaluate the imaging and plan workflow for radiation therapy utilizing this novel device. For this protocol, only the MRI scanner of the machine will be utilized. The 60Co portion of the machine capable of radiation treatment administration will not be utilized, and there will be no experimental treatments or modifications to each patient's standard of care radiation treatment plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Device: Magnetic resonance imagingParticipants will have a custom immobilization device created for them for the purpose of the study. They will be scanned from one to four occasions during radiation treatment. If enrolled in the study prior to the first radiation treatment, the first imaging scan may be scheduled prior to the first radiation treatment, with subsequent scans during treatment separated by at least one day. Patients will be in the scanner for approximately 30 minutes to one hour, either prior to or following their standard of care radiotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Magnetic resonance imagingAlso: MRI | Device | MRI |
Primary outcome
Adequacy of the radiation therapy plan
Time frame: Duration of radiation therapy
The radiation plan will be evaluated based on the recorded clinical goals prescribed by the attending physician. Plans will be classified as 'adequate' if they meet the prescribed goals for the clinical radiation therapy plan.
Feasibility of patient localization workflow
Time frame: Duration of radiation therapy
The localization time will be classified as 'adequate' if it is less than or equal to 15 minutes.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jeff Michalski, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnetic resonance imaging in people with Cancer and Malignant Tumor, run by Washington University School of Medicine 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?
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 20 Feb 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). 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?
Adequacy of the radiation therapy plan (time frame: Duration of radiation therapy). 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 20 Feb 2017.