[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642893":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":55,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":87,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bevonescein (ALM 488) Infusion","EXPERIMENTAL",null,[13],"Drug: Bevonescein (ALM 488) Infusion",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Bevonescein is a synthetic peptide of 17 amino acids conjugated to a fluorescein derivative (5-carboxyfluorescein \\[FAM\\]) and can be visualized using instruments suitable for visualizing fluorescein. Bevonescein selectively binds to extracellular matrix of nerve tissue, increasing nerve visibility and enhancing structure delineation of nerve tissue, potentially reducing the time needed for surgeons to identify nerve tissue and reducing likelihood of nerve injury during thyroidectomy surgery.",[9],[20],{"name":21,"affiliation":22,"role":23},"Matthew E Spector","UPMC Hillman Cancer Center","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Jennifer Ruth","CONTACT","412-623-8963","ruthj2@upmc.edu",{"name":31,"role":27,"phone":32,"phoneExt":11,"email":33},"Mel J Mendez, BS, BS","878-261-6071","mendezmj@upmc.edu",[35],{"facility":36,"status":11,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"UMPC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-79.99589,40.44062,{"lat":46,"lon":45},[49,51,53],{"name":50,"role":27,"phone":28,"phoneExt":11,"email":29},"Jennifer Ruth, RN, BSN",{"name":52,"role":27,"phone":32,"phoneExt":11,"email":33},"Mel J Mendez, BS",{"name":54,"role":23,"phone":11,"phoneExt":11,"email":11},"Matthew E Spector, MD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Matthew Spector","Division Chief, Head & Neck Surgical Oncology & Microvascular Reconstruction",[60],{"name":61,"class":62},"Alume Biosciences, Inc.","INDUSTRY","100642893","phase-2-bevonescein-for-improved-intraoperative-nerve-visualization-to-improve-voice-outcomes-in-thyroidectomy-patients-100642893",false,"NCT07631650","Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients","A Phase 2 Trial of Systemic Administration of Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Patients Undergoing Thyroidectomy","Inclusion Criteria:\n\n1. Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm\n2. Must be a minimum of 18 years old or older\n3. Must be able to give documented informed consent to participate in this study\n4. Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator\n5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n7. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. Previous history of surgery and\u002For radiation to the head, neck, or shoulder\n2. Abnormal cardiac rhythm not controlled with medication\n3. The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator\n4. Presence or history of any hypersensitivity to bevonescein (or fluorescein) or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects\n5. Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction (MI) or cerebrovascular accident (CVA)\n6. Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study\n7. Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments\n8. The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.",[80,81],"Head and Neck Disorder","Head and Neck Cancer",[83,84,85,86],"vocal fold immobility","electromyographic (EMG) monitoring","thyroidectomy","intraoperative nerve visualization","NOT_YET_RECRUITING","2026-06-03",{"date":90,"type":91},"2026-06-08","ACTUAL",{"date":93,"type":74},"2026-06-30",{"date":95,"type":74},"2027-08-31",{"name":57,"class":6},1]