Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:28 AM
Study NCT ID:
NCT07469202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CYTALUX Dose Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720187', 'term': 'Pafolacianine'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Lung and ovarian subjects will be classified equally into one of two dosing cohorts as defined below:\n\n* Lung Cohort 1: Subjects with malignant and non-malignant lesions in the lung dosed 1-24 hours prior to imaging\n* Lung Cohort 2: Subjects with malignant and non-malignant lesions in the lung dosed 120 - 168 hours prior to imaging\n* Ovarian Cohort 1: Subjects with ovarian cancer dosed 1-9 hours prior to imaging\n* Ovarian Cohort 2: Subjects with ovarian cancer dosed 120 - 168 hours prior to imaging'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor-to-background ratio', 'timeFrame': '1 day', 'description': 'Mean difference in in-situ tumor-to-background ratio (TBR) between 120-168 hours and the approved window'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '1 day', 'description': 'The sensitivity of Cytalux™ (pafolacianine) with NIR imaging for detection of malignant and non-malignant lung lesions and malignant ovarian cancer lesions. The sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer.'}, {'measure': 'Sensitivity of folate receptor-positive lesions', 'timeFrame': '1 day', 'description': 'The sensitivity of Cytalux with NIR imaging for detection of malignant and non-malignant lung lesions and for malignant ovarian cancer lesions that are confirmed to be folate receptor alpha and/or folate receptor beta positive'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer in the lung', 'lung cancer', 'ovarian cancer', 'lung cancer surgery', 'ovarian cancer surgery', 'CYTALUX', 'pafolacianine', 'fluorescent', 'molecular imaging'], 'conditions': ['Cancer in the Lung', 'Ovarian Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7. PMID: 36070540; PMCID: PMC12684809.'}, {'type': 'BACKGROUND', 'citation': 'Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3. PMID: 37019717; PMCID: PMC12507096.'}], 'seeAlsoLinks': [{'url': 'https://cytaluxhcp.com/wp-content/uploads/2025/08/cytalux-uspi-july-2025.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.', 'detailedDescription': 'This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer.\n\nThe study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer.\n\nEligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows.\n\nDuring surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™.\n\nThe primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female patients 18 years of age and older\n2. Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer\n3. Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction\n4. Willingness of research participant or legal guardian/representative to give written informed consent\n\nExclusion Criteria:\n\n1. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.\n2. History of allergy to any of the components of Cytalux™ (pafolacianine)\n3. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n4. Known sensitivity to fluorescent light\n5. Impaired renal function defined as eGFR\\< 50 mL/min/1.73m2\n6. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin excluding those patients with Gilbert's syndrome\n7. Pregnant and/or lactating women\n8. Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)"}, 'identificationModule': {'nctId': 'NCT07469202', 'briefTitle': 'CYTALUX Dose Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'On Target Laboratories, LLC'}, 'officialTitle': 'Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer', 'orgStudyIdInfo': {'id': 'OTL38-2026-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lung dosing 1-24 hours prior to imaging', 'description': 'Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 1-24 hours prior to imaging', 'interventionNames': ['Drug: CYTALUX (pafolacianine) injection']}, {'type': 'EXPERIMENTAL', 'label': 'Lung dosing 120-168 hours prior to imaging', 'description': 'Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging', 'interventionNames': ['Drug: CYTALUX (pafolacianine) injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ovarian dosing 1-9 hours prior to imaging', 'description': 'Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 1-9 hours prior to imaging', 'interventionNames': ['Drug: CYTALUX (pafolacianine) injection']}, {'type': 'EXPERIMENTAL', 'label': 'Ovarian dosing 120-168 hours prior to imaging', 'description': 'Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging', 'interventionNames': ['Drug: CYTALUX (pafolacianine) injection']}], 'interventions': [{'name': 'CYTALUX (pafolacianine) injection', 'type': 'DRUG', 'otherNames': ['pafolacianine injection'], 'description': 'CYTALUX™ (PAFOLACIANINE) INJECTION: folate analog ligand conjugated with an indole cyanine green-like dye. Each subject will be administered a single intravenous dose (0.025 mg/kg) based on their assigned cohort before initiation of intraoperative NIR fluorescent imaging', 'armGroupLabels': ['Lung dosing 1-24 hours prior to imaging', 'Lung dosing 120-168 hours prior to imaging', 'Ovarian dosing 1-9 hours prior to imaging', 'Ovarian dosing 120-168 hours prior to imaging']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tina Barrett', 'role': 'CONTACT', 'email': 'tbarrett@ontargetlabs.com', 'phone': '765-588-4547'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information is not relevant to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'On Target Laboratories, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}