[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520160":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":72,"centralContacts":81,"locations":89,"responsibleParty":117,"collaborators":60,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":60,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":60,"enrollmentInfo":129,"targetDuration":60,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":141,"whyStopped":60,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"MB-PDT at pre-defined dose plus standard of care abscess drainage","EXPERIMENTAL","Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, and laser illumination at an optical power defined by their abscess size.",[13,14,15,16,17],"Drug: Methylene Blue","Drug: Lipid Emulsion","Device: Insertion of optical fiber","Device: Laser Illumination (pre-defined dose)","Procedure: Standard of care abscess drainage",{"label":19,"type":10,"description":20,"interventionNames":21},"MB-PDT at patient-specific dose plus standard of care abscess drainage","Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, optical spectroscopy, and laser illumination. The optical power for laser illumination will be determined by their abscess morphology and the results of optical spectroscopy.",[13,14,15,22,23,17],"Device: Optical Spectroscopy Measurement","Device: Laser Illumination (patient-specific dose)",{"label":25,"type":6,"description":26,"interventionNames":27},"Standard of care abscess drainage","Each subject in this arm will receive standard of care abscess drainage",[17],[29,36,43,50,56,61,66],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Methylene Blue","Administration of 0.1 mg\u002FmL methylene blue to the abscess cavity, followed by a 10 minute incubation interval. After this incubation interval, the methylene blue solution will be aspirated from the cavity and flushed twice with sterile saline.",[19,9],[35],"Methylene Blue Injection, 1%",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Lipid Emulsion","The abscess cavity will be filled with sterile 0.1% lipid emulsion solution to gently distend the cavity and, through efficient light scattering, to homogenize the light dose to the walls of the cavity. After laser illumination, the Intralipid will be aspirated from the cavity.",[19,9],[41,42],"Intralipid 20%","Nutrilipid 20%",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DEVICE","Insertion of optical fiber","A sterile, FDA-approved optical fiber will be advanced to the approximate center of the abscess cavity via the drainage catheter under image guidance. Following laser illumination, the fiber will be withdrawn.",[19,9],[49],"Boston Scientific Flexiva Pulse ID",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Laser Illumination (pre-defined dose)","Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set such that the fluence rate at the abscess wall due to ballistic photons is 20 mW\u002Fcm2.",[9],[55],"Modulight ML7710 Laser System",{"type":44,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Optical Spectroscopy Measurement","The same sterile optical fiber used for treatment will be advanced through the drainage catheter\u002Fneedle in order to make gentle contact with the wall of the cavity. Low-intensity, polarized white light will be delivered by a tungsten halogen lamp by the fiber, and captured by the same fiber. Light that has been de-polarized by interaction with tissue will be detected by a spectrometer and analyzed to extract tissue optical properties. Upon completion of these measurements, the fiber optic will be withdrawn, gently wiped with sterile gauze, and returned to the procedure cart.",[19],null,{"type":44,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Laser Illumination (patient-specific dose)","Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set to deliver a fluence rate of 20 mW\u002Fcm2 in 95% of the abscess wall, based upon abscess morphology and optical spectroscopy results.",[19],[55],{"type":67,"name":25,"description":68,"armGroupLabels":69,"otherNames":70},"PROCEDURE","Following standard practice, a drainage catheter will be placed in the abscess cavity and used to aspirate purulent fluid.",[19,9,25],[71],"Image-guided percutaneous drainage",[73,76,78],{"name":74,"affiliation":5,"role":75},"Timothy M Baran, PhD","PRINCIPAL_INVESTIGATOR",{"name":77,"affiliation":5,"role":75},"Ashwani K Sharma, MD",{"name":79,"affiliation":5,"role":80},"Laurie Christensen, BS","STUDY_DIRECTOR",[82,86],{"name":74,"role":83,"phone":84,"phoneExt":60,"email":85},"CONTACT","585-276-3188","Timothy_Baran@URMC.Rochester.edu",{"name":77,"role":83,"phone":87,"phoneExt":60,"email":88},"585-276-5491","Ashwani_Sharma@URMC.Rochester.edu",[90,108],{"facility":91,"status":60,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Highland Hospital","Rochester","New York","14620","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-77.61556,43.15478,{"lat":101,"lon":100},[104,105],{"name":74,"role":83,"phone":84,"phoneExt":60,"email":85},{"name":79,"role":83,"phone":106,"phoneExt":60,"email":107},"585-275-8849","Laurie_Christensen@URMC.Rochester.edu",{"facility":109,"status":60,"city":92,"state":93,"zip":110,"country":95,"countryCode":96,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"University of Rochester Medical Center","14642",{"type":98,"coordinates":112},[100,101],{"lat":101,"lon":100},[115,116],{"name":74,"role":83,"phone":84,"phoneExt":60,"email":85},{"name":79,"role":83,"phone":106,"phoneExt":60,"email":107},{"type":75,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Timothy Baran","Assistant Professor","100520160","phase-2-efficacy-of-methylene-blue-photodynamic-therapy-for-treatment-of-deep-tissue-abscesses-100520160",false,"NCT06052956","Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses","A Phase 2 Study to Assess Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses","Inclusion Criteria:\n\n* Adults 18 years or older\n* All patients with clinical symptoms (ex: fever, chills, pain, tachycardia, hypotension), laboratory (leukocytosis) and radiologic findings (thick walled, rim-enhancing collection with gas bubbles or air-fluid levels) compatible with an abscess that requires image- guided percutaneous drainage\n* Approval by the primary care team to pursue PDT and discuss enrollment with the patient\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Allergy to contrast media, narcotics, sedatives, atropine or eggs\n* Necrotic tissue that requires surgical debridement\n* Severely compromised cardiopulmonary function or hemodynamic instability\n* Thrombocytopenia (\\\u003C50,000\u002Fmm3)\n* Uncorrectable coagulopathy\n* Poor kidney function (serum creatinine \\>3mg\u002Fdl)\n* Lack of a safe pathway to the abscess or fluid collection\n* Unable or unwilling to understand or to provide informed consent\n* Unable or unwilling to undergo study procedures\n* Patient unable to cooperate with, or to be positioned for the procedure\n* Unable to comply with necessary follow up\n* Patients with pancreatic abscesses\n* Patients with known fistulous communication with their abscess\n* Abscess greater than 13 cm in diameter","ALL","18 Years",{"count":130,"type":131},120,"ESTIMATED","INTERVENTIONAL",[134],"PHASE2","The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug\u002Flight dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.",[137],"Abscess",[137,139,140],"Drainage","Photodynamic Therapy","NOT_YET_RECRUITING","2026-02-05",{"date":144,"type":145},"2026-02-10","ACTUAL",{"date":147,"type":131},"2026-07-15",{"date":149,"type":131},"2031-06-30",{"name":5,"class":6},2]