Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02790294
Eligibility Criteria:
Inclusion Criteria:
* 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.
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02790294
Study Brief:
Protocol Section:
NCT02790294