Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 4:19 PM
Study NCT ID:
NCT06599151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577112', 'term': '6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All enrolled subjects (Pain Patients and Healthy Volunteers) will be injected with 5-10 mCi of \\[18F\\]FTC-146 and undergo a PET/MRI scan.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodistribution of [18F]FTC-146- correlate with reported pain', 'timeFrame': 'Estimated average of 4 hours', 'description': "Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/MRI', 'Chronic Pain', 'Nerve Pain'], 'conditions': ['Nerve Pain', 'Neuropathic Pain', 'Nociceptive Pain', 'MIxed Pain (Nociceptive and Neuropathic)']}, 'referencesModule': {'references': [{'pmid': '28824716', 'type': 'BACKGROUND', 'citation': 'Shen B, Behera D, James ML, Reyes ST, Andrews L, Cipriano PW, Klukinov M, Lutz AB, Mavlyutov T, Rosenberg J, Ruoho AE, McCurdy CR, Gambhir SS, Yeomans DC, Biswal S, Chin FT. Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI. Theranostics. 2017 Jul 8;7(11):2794-2805. doi: 10.7150/thno.19378. eCollection 2017.'}, {'pmid': '28280965', 'type': 'BACKGROUND', 'citation': 'Shen B, Park JH, Hjornevik T, Cipriano PW, Yoon D, Gulaka PK, Holly D, Behera D, Avery BA, Gambhir SS, McCurdy CR, Biswal S, Chin FT. Radiosynthesis and First-In-Human PET/MRI Evaluation with Clinical-Grade [18F]FTC-146. Mol Imaging Biol. 2017 Oct;19(5):779-786. doi: 10.1007/s11307-017-1064-z.'}, {'pmid': '24337599', 'type': 'BACKGROUND', 'citation': 'James ML, Shen B, Nielsen CH, Behera D, Buckmaster CL, Mesangeau C, Zavaleta C, Vuppala PK, Jamalapuram S, Avery BA, Lyons DM, McCurdy CR, Biswal S, Gambhir SS, Chin FT. Evaluation of sigma-1 receptor radioligand 18F-FTC-146 in rats and squirrel monkeys using PET. J Nucl Med. 2014 Jan;55(1):147-53. doi: 10.2967/jnumed.113.120261. Epub 2013 Dec 12.'}, {'pmid': '19326101', 'type': 'BACKGROUND', 'citation': 'Entrena JM, Cobos EJ, Nieto FR, Cendan CM, Baeyens JM, Del Pozo E. Antagonism by haloperidol and its metabolites of mechanical hypersensitivity induced by intraplantar capsaicin in mice: role of sigma-1 receptors. Psychopharmacology (Berl). 2009 Jul;205(1):21-33. doi: 10.1007/s00213-009-1513-8. Epub 2009 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the uptake of \\[18F\\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain with Spinal or Peripheral Nerve Origin.\n\nPrimary Objectives:\n\nA) To quantify the bio-distribution of \\[18F\\] FTC-146 uptake in subjects with Spinal or Peripheral Nerve Origin pain and compare it with healthy controls.\n\nB) To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging.\n\nSecondary Objectives:\n\nA) To assess the reproducibility of \\[18F\\]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis.\n\nB) To investigate whether post-treatment \\[18F\\]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment', 'detailedDescription': "Chronic pain represents a significant and widespread problem affecting approximately one-fifth person of the global population. As reported by the Institute of Medicine in 2011, chronic pain impacts 116 million American adults, surpassing the combined prevalence of heart disease, cancer, and diabetes. The economic burden associated with chronic pain is staggering, with an estimated annual expenditure of $635 billion on medical management and lost productivity1. Chronic pain can interfere with a person's daily life and lead to depression, insomnia and anxiety which can make the chronic pain worse. Chronic pain has many forms and appears across the body. For this study we will focus on chronic pain with spinal or peripheral nerve origin.\n\nChronic pain in the spinal cord or peripheral nerves can be caused by neuropathic pain, which occurs when the nervous system is damaged or malfunctions. Tumors, specifically schwannomas, are known to cause neuropathic chronic pain in subjects. The chronic pain can also be caused by nociceptive pain which is a type of pain that occurs when body tissue is damaged by physical or chemical agents, such as trauma, surgery, or chemical burns.\n\nPain is common and debilitating in people with schwannomatosis: Pain is the defining feature of most forms of schwannomatosis. While neurologic deficits (e.g., weakness) are relatively rare, pain is extremely common. Pain correlates with greater disability, and pain-related interference in daily activities correlates with poorer quality of life.\n\nIn patients with schwannomatosis, due to the presence of multiple tumors and frequent non-tumorigenic sources of pain, identifying the pain-generating tumor(s) can be difficult. This is particularly true since there does not seem to be any correlation between tumor size or active tumor growth and pain. Furthermore, even when pain can be localized to a specific nerve distribution, the nerve in question often will have multiple tumors along its course.\n\nCurrent clinical methods for diagnosing and localizing pain generators are inadequate, highlighting the urgent need for more objective molecular assays capable of identifying sites of enhanced nociceptive activity. This will facilitate better diagnosis and targeted therapy for the patient. Additionally, the limited number availability of analgesic options for chronic and neuropathic pain patients, coupled with significant adverse effects, underscores the critical need for safer and better-tolerated analgesics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy Volunteers\n\n 1\\. At least 18 years old.\n* Pain Subjects\n\n 1. At least 18 years old.\n 2. Chronic Pain is of Spinal or Peripheral Nerve Origin\n 3. Subject's Chronic pain lasting greater than 2 months.\n 4. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.\n\nExclusion Criteria:\n\n* Healthy Volunteers\n\n 1. Any chronic Pain\n 2. Use of pain medication.\n 3. MRI incompatibility.\n 4. Kidney problems.\n 5. Pregnant or nursing.\n 6. Non-English speaker.\n 7. Presence of vasculopathy or Raynaud's.\n 8. Inability to tolerate cessation of anticoagulant medication during the study.\n* Pain Subjects\n\n 1. MRI incompatibility.\n 2. Kidney problems.\n 3. Pregnant or nursing.\n 4. Non-English speaker."}, 'identificationModule': {'nctId': 'NCT06599151', 'briefTitle': 'PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Use of (18F)FTC-146 PET_MRI for Characterizing Chronic Pain Phenotypes in Chronic Pain Patients with Spinal or Peripheral Nerve Origin', 'orgStudyIdInfo': {'id': '76036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Patients With Spinal or Peripheral Nerve Origin', 'description': 'Individuals suffering from nerve pain that is of spinal or peripheral nerve origin and undergo a \\[18F\\]FTC-146 PET/MRI scan.', 'interventionNames': ['Drug: [18F]FTC-146']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': 'Individuals who do not have pain and undergo a \\[18F\\]FTC-146 PET/MRI scan.', 'interventionNames': ['Drug: [18F]FTC-146']}], 'interventions': [{'name': '[18F]FTC-146', 'type': 'DRUG', 'description': 'Adult participants will be injected with 5-10 mCi of \\[18F\\]FTC-146 and undergo a PET/MRI scan.', 'armGroupLabels': ['Healthy Volunteers', 'Pain Patients With Spinal or Peripheral Nerve Origin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adrian Valladarez', 'role': 'CONTACT', 'email': 'adrian98@stanford.edu', 'phone': '(650) 381-4257'}, {'name': 'Neurosurgery Research Team', 'role': 'CONTACT', 'email': 'neurosurgeryresearch@stanford.edu'}], 'overallOfficials': [{'name': 'Anand Veeravagu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University- Neurosurgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Asst. Professor', 'investigatorFullName': 'Anand Veeravagu', 'investigatorAffiliation': 'Stanford University'}}}}