Nctid:
NCT06227585
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-11-16", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Surgeon perspective on REVEAL 475 system blue light illumination", "timeFrame"=>"Immediately after surgery", "description"=>"Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome"}, {"measure"=>"Surgeon perspective on REVEAL 475 system ease of use", "timeFrame"=>"Immediately after surgery", "description"=>"Surgeon to provide responses to questions on a Likert scale 1-5 where a higher score means a better outcome"}], "secondaryOutcomes"=>[{"measure"=>"Plasma concentration of bevonescein", "timeFrame"=>"1.5-5 hours before surgery, during surgery, and 0-12 hours after surgery", "description"=>"Measurement of the concentration of bevonescein in plasma from all patients immediately before, during and immediately after surgery."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["parotidectomy", "thyroidectomy", "neck dissection", "ALM-488", "bevonescein", "nerve", "fluorescence", "head and neck surgery", "intra-operative", "real-time", "REVEAL 475"], "conditions"=>["Head and Neck Surgery"]}, "descriptionModule"=>{"briefSummary"=>"A feasibility study to evaluate the usability of the REVEAL 475 system in patients treated with bevonescein for nerve visualization during surgery.", "detailedDescription"=>"The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration. All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before undergoing parotidectomy, thyroidectomy or neck dissection surgery."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Minimum of 16 years of age.\n* Planning to undergo surgery in the Head and Neck.\n* Study participant's primary surgical treatment is parotidectomy or thyroidectomy (unilateral or bilateral) or cervical neck dissection.\n* Willing and able to provide written assent as required and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.\n* Sexually active patients must be willing to use an acceptable method of contraception while participating in the study and for 30 days after receiving bevonescein.\n* Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.\n\nExclusion Criteria:\n\n* Patient has a history of prior surgery and/or radiation to the intended surgical site.\n* Patient has abnormal cardiac rhythm not controlled with medication.\n* Patient has moderate to severe renal impairment as indicated by a glomerular filtration rate (GFR) \\< 60 mL/min.\n* Patient has decreased hepatic function defined as AST/SGOT and ALT/SGPT that is higher than 20% of the institution's normal laboratory limits, and/or the patient has elevated total bilirubin that is higher than 20% of the institution's normal laboratory limits.\n* Patient has unresolved acute toxicity from prior anti-cancer therapy, alopecia, neuropathy \\<= Grade 2, as well as other non-acute and stable anti-cancer therapy toxicities are acceptable.\n* Patient has a history of fluorescein allergy.\n* Patient has a history of drug-related anaphylactic or severe allergic reactions.\n* Presense or history of any hypersensitivity to bevonescein or its excipients that, in the judgment of the Investigator, places the patient at increased risk for adverse effects.\n* 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, or cerebrovascular accident.\n* 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.\n* Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) at any time during the study.\n* Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments."}, "identificationModule"=>{"nctId"=>"NCT06227585", "briefTitle"=>"Feasibility Study- REVEAL 475 for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Alume Biosciences, Inc."}, "officialTitle"=>"Feasibility Study- REVEAL 475 System for Bevonescein-Assisted Intra-Operative Visualization of Nerves in Head and Neck Surgery", "orgStudyIdInfo"=>{"id"=>"ALM-488-003"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Single Arm (Bevonescein)", "description"=>"All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients.", "interventionNames"=>["Device: REVEAL 475 System", "Drug: Bevonescein"]}], "interventions"=>[{"name"=>"REVEAL 475 System", "type"=>"DEVICE", "description"=>"The REVEAL 475 system will be evaluated for its ability to visualize nerve-fluorescence following bevonescein administration.", "armGroupLabels"=>["Single Arm (Bevonescein)"]}, {"name"=>"Bevonescein", "type"=>"DRUG", "otherNames"=>["ALM-488"], "description"=>"All patients will receive a single dose of bevonescein 500 mg via IV infusion 1-5 hours before surgery.", "armGroupLabels"=>["Single Arm (Bevonescein)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92093", "city"=>"San Diego", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael Bouvet, MD", "role"=>"CONTACT", "email"=>"mbouvet@health.ucsd.edu", "phone"=>"858-246-2223"}], "facility"=>"Jacobs Medical Center at UC San Diego Health", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Gregory Randolph, MD", "role"=>"CONTACT", "email"=>"Gregory_Randolph@meei.harvard.edu", "phone"=>"617-523-7900"}], "facility"=>"Harvard-Mass Eye & Ear", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael Singer, MD", "role"=>"CONTACT", "email"=>"msinger1@hfhs.org", "phone"=>"586-263-2269"}], "facility"=>"Henry Ford Health System", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"87131", "city"=>"Albuquerque", "state"=>"New Mexico", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Ryan Orosoco, MD", "role"=>"CONTACT"}, {"role"=>"CONTACT", "email"=>"RKOrosco@salud.unm.edu", "phone"=>"505-272-2111"}], "facility"=>"University of New Mexico", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Karthik Rajasekaran, MD", "role"=>"CONTACT", "email"=>"Karthik.Rajasekaran@pennmedicine.upenn.edu", "phone"=>"215-829-5180"}], "facility"=>"University of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Joseph Curry, MD", "role"=>"CONTACT", "email"=>"joseph.curry@jefferson.edu"}], "facility"=>"Thomas Jefferson University", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"29425", "city"=>"Charleston", "state"=>"South Carolina", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Jason Newman, MD", "role"=>"CONTACT", "email"=>"newmajas@musc.edu", "phone"=>"843-792-9300"}], "facility"=>"MUSC- Hollings Cancer Center", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}], "centralContacts"=>[{"name"=>"Brett Berman, MD", "role"=>"CONTACT", "email"=>"brett.berman@alumebiosciences.com", "phone"=>"858-922-3977"}, {"name"=>"Kim Potter", "role"=>"CONTACT", "email"=>"kim.potter@alumebiosciences.com", "phone"=>"706-338-1158"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Alume Biosciences, Inc.", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Ergomed", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
