Spinal MetastasesNCT05155423
A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy
An observational study of Spinal Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- mask for immobilization and Elekta BodyFix
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2018to 24 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: MDACC Cancer Participants
3.1. Inclusion Criteria
- Greater than or equal to 18 years of age
- Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
- Signed informed consent
- Willing to undergo 2 MRI simulations in one or multiple sessions, one with immobilization device, and the other without.
- Patients undergoing spinal SBRT 3.2. Exclusion Criteria
- Patient with a relative or absolute contraindication to MRI (such as pacemaker, etc.) b. Patients with significant instrumentation or cement at the site of interest causing artifact c. Inability to tolerate with immobilization device for greater than 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery.
Read the detailed description
- Objectives
- Assess the feasibility of performing MRI scans in the treatment position for accurate treatment planning and dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
- Characterize the improved accuracy of image fusion between MRI and CT and its dosimetric impact when performing MRI scans in treatment position in spinal SBRT.
- Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (>3 consecutive vertebral body levels)
- Optimize the workflow of using MRI simulation in treatment planning and dose delivery.
- Conditions
- Spinal Metastases
- Being tested
- mask for immobilization, Elekta BodyFix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mask for immobilizationOther
mask for immobilization
Elekta BodyFixOther
Elekta BodyFix
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patient using mask for immobilization Receives: Other: mask for immobilization | |
| group 2 | patients using Elekta BodyFix Receives: Other: Elekta BodyFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performing MRI scans in the treatment position for accurate treatment planning.
Measured: through study completion, an average of 1 year
Performing MRI scans in the treatment position for dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start21 Apr 2018
- Primary completion24 May 2026 (estimated)
- Study completion24 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Elekta Limited
- Responsible party
- Sponsor
- Investigators
- Amol Ghia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155423
- Sponsor's protocol ID
- PA18-0190
- Other IDs
- NCI-2021-11703
- Status last verified
- May 2026
- First submitted
- 30 Nov 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT05155423
- Acronym / sponsor ID
- PA18-0190
- Conditions
- Spinal Metastases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Elekta Limited
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 24 May 2026 (estimated)
- Study completion
- 24 May 2026 (estimated)
- First posted
- 13 Dec 2021 (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.
To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery.
Detailed description
- Objectives
- Assess the feasibility of performing MRI scans in the treatment position for accurate treatment planning and dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
- Characterize the improved accuracy of image fusion between MRI and CT and its dosimetric impact when performing MRI scans in treatment position in spinal SBRT.
- Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (>3 consecutive vertebral body levels)
- Optimize the workflow of using MRI simulation in treatment planning and dose delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: mask for immobilizationpatient using mask for immobilization |
| group 2 | – | Other: Elekta BodyFixpatients using Elekta BodyFix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MDACC Cancer Participants
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 |
|---|---|---|
| mask for immobilizationmask for immobilization | Other | group 1 |
| Elekta BodyFixElekta BodyFix | Other | group 2 |
Primary outcome
Performing MRI scans in the treatment position for accurate treatment planning.
Time frame: through study completion, an average of 1 year
Performing MRI scans in the treatment position for dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- M D Anderson Cancer CenterLink 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.
Amol Ghia, MD principal investigator
M.D. Anderson Cancer Center
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 Spinal Metastases, run by M.D. Anderson Cancer Center 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: under way, not looking for participants, as of the sponsor's last update on 18 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Performing MRI scans in the treatment position for accurate treatment planning. (time frame: through study completion, an average of 1 year). 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 18 May 2026.