Spinal TumorNCT02790294
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal
A study testing Magnetic Resonance Imaging in people with Spinal Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2016to 17 Dec 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space
- Operated for debulking, decompression or separation surgery;
- A magnetic resonance imaging (MRI) scan performed within 72 hours after surgery is needed;
- Image quality acceptable for comparison with later MRI as read by a neuroradiologist;
- Karnofsky score of 60 or higher;
- Able to consent for the study.
Who cannot join
- Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes.
- Intradural extension of the tumor.
- Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study.
- Patient not able to tolerate MRI scan due to claustrophobia or severe pain or allergic reaction to contrast.
- Patients with an estimated Glomerular Filtration Rate (eGFR) < or = to 30 will be excluded to avoid issues related to contrast administration in such patients. This Glomerular Filtration Rate (GFR) threshold cutoff level is chosen per institutional policy, because below that level other measures would be required (hydration or no contrast administration). In order to keep the imaging information as uniform as possible in such a small study group, patients with a low GFR will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). The purpose of this study is to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.
In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.
Read the detailed description
Primary aim:
Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI.
Secondary aims:
Investigate the differences between early and late MRI by comparing:
- Size of tumor in three dimensions;
- Extent of edema;
- Presence and extent of fluid collection;
- Spine Oncology Study Group score;
- Involvement of adjacent levels;
- Progression of tumor;
- Patient's preference/performance scale right after each image had taken: level of discomfort at around the time each MRI was performed.
Study Design:
This is a prospective diagnostic study for which no standard of care currently exists.
- Conditions
- Spinal Tumor
- Being tested
- Magnetic Resonance Imaging
- Keywords
- magnetic resonance imaging
- Medical subject headings
- Spinal Cord 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
The routine spine MRI protocol will be utilized, which includes the following sequences: haste localizer, sagittal T1, T2, and short-T1 Inversion Recovery (STIR), axial T2 for lumbar spine or axial gradient echo for cervical and thoracic spine, axial T1, post contrast sagittal and axial T1. All scans will be obtained using a 1.5 Tesla magnet.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Magnetic Resonance Imaging | Experimental | Three MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative. Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging
Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery (aka: later imaging) leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI (within 72 hours, aka: early imaging).
Measured: Up to 3 weeks after surgery
Secondary outcomes (3)
Change in tumor volume between immediate and later postoperative MRI
Measured: Up to 3 weeks after surgery
Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs
Measured: Up to 3 weeks after surgery
Progression of tumor using RECIST Criteria
RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Measured: Up to 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start31 Aug 2016
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lilyana Angelov, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790294
- Sponsor's protocol ID
- CASE4314
- Status last verified
- May 2024
- First submitted
- 31 May 2016
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal Tumors - a Pilot Study
- ClinicalTrials.gov ID
- NCT02790294
- Acronym / sponsor ID
- CASE4314
- Conditions
- Spinal Tumor
- Keywords
- magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 3 Jun 2016 (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.
This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). The purpose of this study is to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.
In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.
Detailed description
Primary aim:
Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI.
Secondary aims:
Investigate the differences between early and late MRI by comparing:
- Size of tumor in three dimensions;
- Extent of edema;
- Presence and extent of fluid collection;
- Spine Oncology Study Group score;
- Involvement of adjacent levels;
- Progression of tumor;
- Patient's preference/performance scale right after each image had taken: level of discomfort at around the time each MRI was performed.
Study Design:
This is a prospective diagnostic study for which no standard of care currently exists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Magnetic Resonance Imaging | Experimental | Device: Magnetic Resonance ImagingThree MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space
- Operated for debulking, decompression or separation surgery;
- A magnetic resonance imaging (MRI) scan performed within 72 hours after surgery is needed;
- Image quality acceptable for comparison with later MRI as read by a neuroradiologist;
- Karnofsky score of 60 or higher;
Key exclusion criteria (5 listed)
- Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes.
- Intradural extension of the tumor.
- Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study.
- Patient not able to tolerate MRI scan due to claustrophobia or severe pain or allergic reaction to contrast.
- Patients with an estimated Glomerular Filtration Rate (eGFR) < or = to 30 will be excluded to avoid issues related to contrast administration in such patients. This Glomerular Filtration Rate (GFR) threshold cutoff level is chosen per institutional policy, because below that level other measures would be required (hydration or no contrast administration). In order to keep the imaging information as uniform as possible in such a small study group, patients with a low GFR will not be enrolled in the study.
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: MRIThe routine spine MRI protocol will be utilized, which includes the following sequences: haste localizer, sagittal T1, T2, and short-T1 Inversion Recovery (STIR), axial T2 for lumbar spine or axial gradient echo for cervical and thoracic spine, axial T1, post contrast sagittal and axial T1. All scans will be obtained using a 1.5 Tesla magnet. | Device | Postoperative Magnetic Resonance Imaging |
Primary outcome
Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging
Time frame: Up to 3 weeks after surgery
Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery (aka: later imaging) leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI (within 72 hours, aka: early imaging).
3 secondary outcomes
Change in tumor volume between immediate and later postoperative MRI
Time frame: Up to 3 weeks after surgery
Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs
Time frame: Up to 3 weeks after surgery
Progression of tumor using RECIST Criteria
Time frame: Up to 3 weeks after surgery
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 14 May 2024.
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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.
Lilyana Angelov, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive 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 Magnetic Resonance Imaging in people with Spinal Tumor, run by Case Comprehensive 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 6 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: finished, as of the sponsor's last update on 14 May 2024. 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?
Number of patients which have the same clinical decision from the immediate postoperative MRI and later imaging (time frame: Up to 3 weeks after surgery). 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 14 May 2024.