[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Matthew Spector\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Head and Neck Disorder","Head and Neck Cancer",[29,30,31,32],"vocal fold immobility","electromyographic (EMG) monitoring","thyroidectomy","intraoperative nerve visualization","NOT_YET_RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":20},"2026-06-30",{"date":41,"type":20},"2027-08-31",{"name":43,"class":44},"Matthew Spector","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100625472","phase-2-window-of-opportunity-in-preserving-laryngeal-function-trial-100625472","NCT07423078","Window of Opportunity in Preserving Laryngeal Function Trial","A Phase II Window of Opportunity in Preserving Laryngeal Function (WOLF) Trial","WOLF","Inclusion Criteria:\n\n1. Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx\n2. AJCC 8th Edition Stage III - IV disease (T1-T2\u002FN1-N3, T3-T4\u002FN0-N3)\n3. Disease (primary \\& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT\n4. ECOG PS 0 - 2\n5. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). 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: 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. Must have normal organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelet count ≥ 100,000\u002FmcL\n   * Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)\n   * AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN)\n   * ALT (SGPT) ≤ 2.5 X institutional ULN\n   * Creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 for patients with a creatinine level above institutional normal\n8. Must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Prior treatment for head and neck cancer\n2. Unresectable laryngeal or hypopharyngeal squamous cell carcinoma\n3. Distant metastatic disease\n4. Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study.\n5. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n6. Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.\n7. Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient.\n8. Peripheral sensory neuropathy \\> grade 2 by CTCAE v5.0\n9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n10. Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection (see note).\n\n    1. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.\n    2. Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥350 cells\u002FµL and the patient has had no opportunistic infections in the last 12 months.",{"count":55,"type":20},87,[23],"This trial will study the safety and tolerability and disease survival rates in adult patients with recurrent\u002Fmetastatic (R\u002FM) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.",[59,60,61],"Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)","Locally Advanced Laryngeal Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma",[63,64,65],"immunotherapy","laryngectomy","neoadjuvant","RECRUITING","2026-04-06",{"date":69,"type":37},"2026-04-13",{"date":67,"type":37},{"date":72,"type":20},"2031-04-30",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100579965","phase-2-use-of-spy-imaging-system-to-minimize-fistulas-after-hypopharyngeal-reconstruction-100579965","NCT06831149","Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction","A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction","Inclusion Criteria:\n\n1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)\n2. Prior treatment with radiation +\u002F- chemotherapy\n3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx\n4. 18 years or older. 5. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. Iodine and Shellfish allergy\n2. Contraindication to surgery under general anesthesia\n3. Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery\n4. Pregnancy or lactation.\n5. Patients residing in prison.",{"count":82,"type":20},225,[23],"Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food.\n\nThe imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery.\n\nFor this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens.\n\nInvestigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.",[86,87],"Squamous Cell Carcinoma","Pharyngocutaneous Fistula",[89,90,91],"squamous cell carcinoma hypopharynx","squamous cell carcinoma larynx","SPY Fluorescence Imaging System","2026-01-07",{"date":94,"type":37},"2026-01-09",{"date":96,"type":37},"2025-02-28",{"date":98,"type":20},"2030-02-28",{"name":43,"class":44},""]