Thoracic CancerNCT04227717
Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine
A study testing MRI with custom MRI spine coil in people with Thoracic Cancer and Spine Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Cancer, Spine Cancer, Thoracic Diseases
- What is being tested?
- MRI with custom MRI spine coil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 14 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- >/= 18 years of age at the time of treatment
- Able to give informed consent
- Consented for spine stereotactic radiation therapy
- No contraindications for CT myelograms which include:
- Allergy to CT contrast
- Use of phenothiazines
Show all 21Show fewer
- Platelet count < 60,000 K/mcl
- INR > 1.5
- VEGF inhibitor use in the past 2 weeks prior to myelogram
- NSAID use in the past 5 days prior to myelogram
- Renal disease
- Creatinine > 1.2 mg/dL
- No contraindications for MRI scans which include:
- Newly placed glucose monitors
- Tattoos (Tattoos for radiation therapy are allowed)
- Presence of a cardiac pacemaker
- Presence of an implanted cardioverter defibrillator
- Breast tissue expander
- Aneurysm clip
- Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
- Severe claustrophobia or inability to lie flat for the duration of the study, etc.
Who cannot join
- Presence of surgical spine hardware at the region of interest
- Presence of cervical spine lesions
- History of claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning
Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.
- Conditions
- Thoracic Cancer, Spine Cancer, Thoracic Diseases, Spine Disease, Thoracic Neoplasms, Spine Metastases
- Being tested
- MRI with custom MRI spine coil
- Keywords
- Thoracic lesions, Lumbar lesions, Sacral spine lesions, MRI Coil, spine radiotherapy, Memorial Sloan Kettering Cancer Center, 19-476
- Medical subject headings
- Spinal Cord Neoplasms, Thoracic Diseases, Spinal Diseases, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with custom MRI spine coilDiagnostic test
Participants will undergo MRI with custom MRI spine coil
| Study group | Role | What they receive |
|---|---|---|
| Thoracic, lumbar and sacral spine lesions | Experimental | Participants will have thoracic, lumbar and sacral spine lesions Receives: Diagnostic Test: MRI with custom MRI spine coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure
The calculated doses to the cauda equine and spinal cord will be compared and evaluated for significant difference based upon the imaging modality (MRI coil vs CT myelogram) used to define each structure, with all other target and avoidance volumes being equal in the same patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start9 Jan 2020
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshiya Yamada, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227717
- Sponsor's protocol ID
- 19-476
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2020
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning
- ClinicalTrials.gov ID
- NCT04227717
- Acronym / sponsor ID
- 19-476
- Conditions
- Thoracic Cancer, Spine Cancer, Thoracic Diseases, Spine Disease, Thoracic Neoplasms, Spine Metastases
- Keywords
- Thoracic lesions, Lumbar lesions, Sacral spine lesions, MRI Coil, spine radiotherapy, Memorial Sloan Kettering Cancer Center, 19-476
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 14 Jan 2020 (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.
Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic, lumbar and sacral spine lesions | Experimental | Diagnostic Test: MRI with custom MRI spine coilParticipants will have thoracic, lumbar and sacral spine lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- >/= 18 years of age at the time of treatment
- Able to give informed consent
- Consented for spine stereotactic radiation therapy
- No contraindications for CT myelograms which include:
- No contraindications for MRI scans which include:
Key exclusion criteria (3 listed)
- Presence of surgical spine hardware at the region of interest
- Presence of cervical spine lesions
- History of claustrophobia
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 |
|---|---|---|
| MRI with custom MRI spine coilParticipants will undergo MRI with custom MRI spine coil | Diagnostic test | Thoracic, lumbar and sacral spine lesions |
Primary outcome
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure
Time frame: 6 months
The calculated doses to the cauda equine and spinal cord will be compared and evaluated for significant difference based upon the imaging modality (MRI coil vs CT myelogram) used to define each structure, with all other target and avoidance volumes being equal in the same patient.
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 18 Jul 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Yoshiya Yamada, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with custom MRI spine coil in people with Thoracic Cancer and Spine Cancer, run by Memorial Sloan Kettering 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?
The sponsor lists 21 inclusion and 3 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 18 Jul 2025. 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?
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure (time frame: 6 months). 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 Jul 2025.