{ "FullStudy":{ "Rank":218229, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511055", "OrgStudyIdInfo":{ "OrgStudyId":"11-002980" }, "Organization":{ "OrgFullName":"Mayo Clinic", "OrgClass":"OTHER" }, "BriefTitle":"Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand", "OfficialTitle":"Phase II, Prospective, Non-Randomized Trial Investigating the Intra-Operative Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand" }, "StatusModule":{ "StatusVerifiedDate":"May 2019", "OverallStatus":"Terminated", "WhyStopped":"Accrual temporarily suspended, followed by study closure due to technical problems with investigational camera.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"May 10, 2019", "DispFirstSubmitQCDate":"May 10, 2019", "DispFirstPostDateStruct":{ "DispFirstPostDate":"May 15, 2019", "DispFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"May 10, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 15, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Sean C. Dowdy", "ResponsiblePartyInvestigatorTitle":"Associate Professor - Obstetrics and Gynecology", "ResponsiblePartyInvestigatorAffiliation":"Mayo Clinic" }, "LeadSponsor":{ "LeadSponsorName":"Mayo Clinic", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.\n\nThis investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Ovarian Cancer" ] }, "KeywordList":{ "Keyword":[ "Ovarian Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"21", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Folate-FITC", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: EC-17" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"EC-17", "InterventionDescription":"One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Folate-FITC" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Folate-FITC" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Sensitivity and specificity of intra-operative imaging using Folate-FITC for identification of ovarian cancer metastatic to the peritoneum and lymph nodes", "PrimaryOutcomeDescription":"A maximum of 5 nodules less than 1cm in size will be identified in each patient with the naked eye and then visualized with the camera. The nodules will be biopsied after determining if they are fluorescent positive or negative (F+ or F-), and examined microscopically to confirm if carcinoma is present. Up to 5 F+ lesions that were not identified with the naked eye will also be biopsied and examined microscopically to determine if carcinoma is present. These data will establish the sensitivity and specificity of this technique using microscopic analysis as the gold standard.", "PrimaryOutcomeTimeFrame":"1 week" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Confirmation of low to absent rates of significant adverse events following a one-time dose of folate-FITC (EC-17).", "SecondaryOutcomeDescription":"Subjects will be followed and all adverse events will be captured for the duration of hospitalization following administration of investigational product, up to a maximum of 7 days following IP administration and surgical procedure.", "SecondaryOutcomeTimeFrame":"Duration of hospitalization with a maximum of 7 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen who are:\n\nDiagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers\nScheduled to undergo surgical cytoreduction via laparotomy\nAt least 18 years of age\nCapable and willing to provide informed consent\n\nExclusion Criteria:\n\nWomen with:\n\nKnown sarcomatous histologies\nRecurrent ovarian cancer\nPlanned surgical approach via laparoscopy or robotic surgery\nA history of anaphylactic reactions to Folate-FITC or insects\nInability or unwillingness to provide informed consent", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sean C Dowdy, MD", "OverallOfficialAffiliation":"Mayo Clinic", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Mayo Clinic", "LocationCity":"Rochester", "LocationState":"Minnesota", "LocationZip":"55905", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Mayo Clinic Clinical Trials", "SeeAlsoLinkURL":"https://www.mayo.edu/research/clinical-trials" } ] } } }, "ResultsSection":{ "MoreInfoModule":{} }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M7201", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16129", "InterventionBrowseLeafName":"Vitamin B Complex", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T446", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T447", "InterventionBrowseLeafName":"Folinic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T448", "InterventionBrowseLeafName":"Folate", "InterventionBrowseLeafAsFound":"Folate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T475", "InterventionBrowseLeafName":"Vitamin B9", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010051", "ConditionMeshTerm":"Ovarian Neoplasms" },{ "ConditionMeshId":"D000077216", "ConditionMeshTerm":"Carcinoma, Ovarian Epithelial" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002277", "ConditionAncestorTerm":"Carcinoma" },{ "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000004701", "ConditionAncestorTerm":"Endocrine Gland Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000010049", "ConditionAncestorTerm":"Ovarian Diseases" },{ "ConditionAncestorId":"D000000291", "ConditionAncestorTerm":"Adnexal Diseases" },{ "ConditionAncestorId":"D000005831", "ConditionAncestorTerm":"Genital Diseases, Female" },{ "ConditionAncestorId":"D000005833", "ConditionAncestorTerm":"Genital Neoplasms, Female" },{ "ConditionAncestorId":"D000014565", "ConditionAncestorTerm":"Urogenital Neoplasms" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" },{ "ConditionAncestorId":"D000006058", "ConditionAncestorTerm":"Gonadal Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11557", "ConditionBrowseLeafName":"Ovarian Neoplasms", "ConditionBrowseLeafAsFound":"Ovarian Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M1704", "ConditionBrowseLeafName":"Carcinoma, Ovarian Epithelial", "ConditionBrowseLeafAsFound":"Ovarian Carcinoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6446", "ConditionBrowseLeafName":"Endocrine Gland Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11555", "ConditionBrowseLeafName":"Ovarian Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2224", "ConditionBrowseLeafName":"Adnexal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7526", "ConditionBrowseLeafName":"Genital Diseases, Female", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7528", "ConditionBrowseLeafName":"Genital Neoplasms, Female", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15898", "ConditionBrowseLeafName":"Urogenital Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7746", "ConditionBrowseLeafName":"Gonadal Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4380", "ConditionBrowseLeafName":"Ovarian Cancer", "ConditionBrowseLeafAsFound":"Ovarian Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T4382", "ConditionBrowseLeafName":"Ovarian Epithelial Cancer", "ConditionBrowseLeafAsFound":"Ovarian Carcinoma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }