Solid CancerNCT02376127
Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
An observational study of Solid Cancer and Metastatic Spinal Lesions, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Metastatic Spinal Lesions
- What is being tested?
- Dynamic contrast enhancement MRI
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2015to 16 Jul 2025
- 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: Research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Who may be able to join
- Adult patients 18 years of age or older
- Known pathological diagnosis of any solid cancer.
- Metastatic spinal lesions 1 cm or greater in diameter.
- Patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions.
- Note: The patients must have their treatments at MSKCC.
Who cannot join
- Patients with renal failure or history of allergic reaction to Gadavist will be excluded.
- Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI.
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
- Patients with inability to cooperate for an MRI exam due to claustrophobia or high levels of anxiety.
- Female patients who are pregnant or nursing.
- Patients with eGFR < 30 are not eligible to higher risk of NSF.
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: Evaluation of Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. The study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.
- Conditions
- Solid Cancer, Metastatic Spinal Lesions
- Being tested
- Dynamic contrast enhancement MRI
- Keywords
- Dynamic Contrast-Enhanced Perfusion, 14-203
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast enhancement MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pts with known spinal metastases | (20 patients from any solid cancer) who are to undergo radiation treatment (RT) will be recruited. The patients will undergo DCE-MRI before and after RT. RT will be classified as success based on evidence of tumor contraction on conventional MRIs, negative PET, or stability for more than 11 months and blinded from DCE MRI sequencing. For each patient, a scanning profile for the first scan will be saved and used for the follow-up scans to acquire the same locations over time. Each patient will be scanned 4 times (one pre-treatment and 3 follow up post treatment) during their consecutive clinical visits. The DCE MRI sequence is a part of MR sequences for standard care. No additional scans will be added in the standard clinical sequences. Receives: Procedure: Dynamic contrast enhancement MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to treatment
will be based on clinical assessment and conventional MRI and PET imaging, evaluating images for evidence of tumor contraction and stable disease for more than 11 months. Clinical assessment is done by radiation oncology and is based on physical examination, patient symptoms and consideration of radiological studies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start24 Feb 2015
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Sasan Karimi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376127
- Sponsor's protocol ID
- 14-203
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2015
- Last updated
- 20 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
- ClinicalTrials.gov ID
- NCT02376127
- Acronym / sponsor ID
- 14-203
- Conditions
- Solid Cancer, Metastatic Spinal Lesions
- Keywords
- Dynamic Contrast-Enhanced Perfusion, 14-203
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 3 Mar 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 purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. The study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts with known spinal metastases | – | Procedure: Dynamic contrast enhancement MRI(20 patients from any solid cancer) who are to undergo radiation treatment (RT) will be recruited. The patients will undergo DCE-MRI before and after RT. RT will be classified as success based on evidence of tumor contraction on conventional MRIs, negative PET, or stability for more than 11 months and blinded from DCE MRI sequencing. For each patient, a scanning profile for the first scan will be saved and used for the follow-up scans to acquire the same locations over time. Each patient will be scanned 4 times (one pre-treatment and 3 follow up post treatment) during their consecutive clinical visits. The DCE MRI sequence is a part of MR sequences for standard care. No additional scans will be added in the standard clinical sequences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Key inclusion criteria (5 listed)
- Adult patients 18 years of age or older
- Known pathological diagnosis of any solid cancer.
- Metastatic spinal lesions 1 cm or greater in diameter.
- Patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions.
- Note: The patients must have their treatments at MSKCC.
Key exclusion criteria (6 listed)
- Patients with renal failure or history of allergic reaction to Gadavist will be excluded.
- Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI.
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
- Patients with inability to cooperate for an MRI exam due to claustrophobia or high levels of anxiety.
- Female patients who are pregnant or nursing.
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 |
|---|---|---|
| Dynamic contrast enhancement MRI | Procedure or surgery | pts with known spinal metastases |
Primary outcome
response to treatment
Time frame: 2 years
will be based on clinical assessment and conventional MRI and PET imaging, evaluating images for evidence of tumor contraction and stable disease for more than 11 months. Clinical assessment is done by radiation oncology and is based on physical examination, patient symptoms and consideration of radiological studies.
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 20 Jul 2025.
- Memorial Sloan Kettering 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.
Sasan Karimi, 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?
An observational study of Solid Cancer and Metastatic Spinal Lesions, 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 5 inclusion and 6 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 20 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?
response to treatment (time frame: 2 years). 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 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.