Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:31 PM
Study NCT ID:
NCT00706459
Status:
TERMINATED
Last Update Posted:
2012-11-14
First Post:
2008-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Disc specimens are taken out during back surgery and will be studied using techniques for tissue analysis to explain the properties and characteristics of disc tissue from patients with back pain.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Due to funding issue, study has been terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2008-06-24', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'In this study, we will use advanced and newly available MR imaging techniques at 3 Tesla (including in situ axial loading and quantitative T1rho, T2, and diffusion measurements) to assess the intervertebral discs and adjacent vertebrae in patients with lumbar back pain scheduled for back surgery (n=20), patients with degenerative disease without classic discogenic back pain (n=10), patients who had discectomies for herniated discs (n=5), and age-matched volunteers without back pain (n=10). In all patients standard imaging procedures will also be performed, including radiographs, standard MRI at 1.5 Tesla and discography. All patients will have specimen of the intervertebral disc harvested at surgery and pathologic analysis and spectroscopy of these specimen will be performed. Post-surgical findings/outcome combined with discography will serve as a standard of reference for the identification of the painful disc(s). The diagnostic performance of the new techniques in assessing the painful disc will be evaluated. We will collect disc specimens from 50 patients undergoing back surgery but did not have pre-surgical MR imaging. These disc specimens will be analyzed in the same manner as the specimens collected from surgical patients who had pre-surgical MRI. This study will serve as a pilot study for a larger project focusing on advanced imaging of the painful intervertebral disc.\n\nWe hypothesis that advanced, dedicated MR examinations at 3T can identify painful degenerated discs in patients with chronic lumbar back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Potential subjects are patients seen by surgeons in the UCSF ACC Orthopedic Clinic. If a patient meets all inclusion and exclusion criteria, the orthopedic surgeon will talk to the patient about the new dedicated examinations using 3 Tesla MRI that can identify painful degenerated discs. When patient is comfortable with participating and has made a decision to go ahead with the MRI, patient can let the orthopedic surgeon's assistant know about his/her decision, the assistant will make sure that patient still meets the inclusion and exclusion criteria and will call the coordinator at the Imaging Center to set up an MRI appointment.\n\nFlyers will be posted at different UCSF campuses to recruit for normal age-matched and young normal volunteers.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Patient with classic discogenic back pain:\n\n* age range 25-60 years old\n* Back and/or leg (back\\>leg) pain\n* Degenerative disc disease in one or more adjacent vertebral levels between L3-S1\n* Radiologic confirmation of degenerative disc disease:\n* Segmental instability (3 mm translation or 5 degree angulation)\n* Decreased disc height \\>2 mm\n* Scarring, thickening of annulus fibrosis\n* Vacuum phenomenon\n* No significant foraminal stenosis and nerve root compression\n* Failed observative treatment for at least 6 months\n* Oswestry LB disability questionnaire score of at least 20/50 (40%) (interpreted as moderate to severe disability)\n* Psychosocially and mentally normal\n* Patients who are scheduled for back surgery\n\nInclusion criteria for patients with degenerative disc disease without the classic discogenic back pain:\n\n* Age range 25-60 years old\n* Patients with diagnosis of idiopathic scoliosis, spondylolysis, or spondylolisthesis\n\nInclusion criteria for normal controls:\n\n* No symptoms\n* Age range 25-60 years old\n\nInclusion Criteria for post-surgical discectomy patients:\n\n* Patients who had successful disc surgery for lumbar herniated disc and no further back pain\n* Patients who had unsuccessful disc surgery for lumbar herniated disc and still with residual back pain\n\nExclusion Criteria:\n\n* prior back surgery (except as mentioned above)\n* spine fractures\n* Radiographic confirmation of facet joint disease or degeneration\n* Radiographic confirmation of sacroiliac joint pathology\n* Lytic spondylolisthesis of spinal stenosis\n* Degenerative spondylolisthesis of \\> grade 1\n* Metabolic bone disease\n* Spine infection , osteomyelitis\n* Rheumatoid arthritis or any other systemic or autoimmune disease\n* Active malignancy\n* MRI Contraindications (fragment in eye, aneurysms clips, ear implants, spinal nerve stimulators, pacemaker, claustrophobia, or pregnant women, etc.,)'}, 'identificationModule': {'nctId': 'NCT00706459', 'briefTitle': 'Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study', 'orgStudyIdInfo': {'id': 'SpineMRI'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with lumbar back pain scheduled for back surgery.', 'interventionNames': ['Device: Magnetic Resonance Imaging']}, {'label': '2', 'description': 'Patients with degenerative disease without classic discogenic back pain', 'interventionNames': ['Device: Magnetic Resonance Imaging']}, {'label': '3', 'description': 'Normal control without back pain.', 'interventionNames': ['Device: Magnetic Resonance Imaging']}, {'label': '4', 'description': 'Post Surgical discectomy patients', 'interventionNames': ['Device: Magnetic Resonance Imaging']}, {'label': '5', 'description': 'disc specimens', 'interventionNames': ['Device: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'description': 'All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.', 'armGroupLabels': ['1', '2', '3', '4', '5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94133', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Sharmila Majumdar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}