ClinicalTrials.gg
CompletedNCT02790294Updated May 14, 2024

Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal

An interventional study of Magnetic Resonance Imaging in Spinal Tumor, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Spinal Cord Neoplasms with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Spinal Cord Neoplasms · United States.

Enrollment
39th of 43
8 · median 35
Started
2016
with 2 others
No phase
11 of 52
1 open now
Registered
37th of 52
by date
Lead sponsor
1 of 52
Case Comprehensive Cancer Center

Among the 52 studies in Spinal Cord Neoplasms with a site in United States, this one is the 39th largest by enrollment of the 43 interventional ones that give a count, is one of 3 that started in 2016, is one of 11 with no phase, and was the 37th registered.

Spinal Cord Neoplasms

105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.

Browse Spinal Cord Neoplasms studies →

Open to participants now

8 of the 52 studies in Spinal Cord Neoplasms with a site in United States are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 23 Spinal Cord Neoplasms studies recruiting now, 15 (65%) set no upper age limit and 5 (22%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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02

Study 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). 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.

03

Conditions studied

  • Spinal Tumor

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Keywords

  • magnetic resonance imaging
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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;
  • score of 60 or higher;
  • Able to consent for the study.

Exclusion criteria

Exclusion Criteria:

  • 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 (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Postoperative Magnetic Resonance Imaging

    Three MRIs will be performed. One at baseline, one within 72 hours postoperative, and one 2-3 weeks postoperative.

    Device: Magnetic Resonance Imaging

Interventions

  • DeviceMagnetic Resonance Imaging

    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.

    Also known as: MRI

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 3 weeks after surgery

Secondary outcomes

  1. Change in tumor volume between immediate and later postoperative MRI

    Time frame: Up to 3 weeks after surgery

  2. Difference in level of discomfort as measured by a visual analog scale between postoperative MRIs

    Time frame: Up to 3 weeks after surgery

  3. 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.

    Time frame: Up to 3 weeks after surgery

07

Study locations

1 site
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Dec 2020, 51 months.

Of 21 interventional studies with no phase under Spinal Cord Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 84. This study's 51 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2016
First posted
Jun 3, 2016
StartActual
Aug 31, 2016
Primary completionActual
Dec 17, 2020
CompletionActual
Dec 17, 2020
Last update
May 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02790294
Responsible party
Sponsor
First posted
Jun 3, 2016
Start date
Aug 31, 2016
Primary completion
Dec 17, 2020
Completion
Dec 17, 2020
Last update
May 14, 2024

Study contacts

Lilyana Angelov, MD
principal investigator · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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