Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06915727
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'C000720187', 'term': 'Pafolacianine'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Each excised specimen will be analyzed for histologic findings to determine accuracy of Cytalux™ (pafolacianine) injection used with near infrared (NIR) fluorescent imaging for detecting lesions. Accuracy will be assessed using sensitivity and specificity.'}], 'secondaryOutcomes': [{'measure': 'Time between Cytalux™ administration and NIR imaging detection intraoperatively', 'timeFrame': 'Day 0 to 1', 'description': 'Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported.'}, {'measure': 'Reasons for not excising NIR avid lesions', 'timeFrame': 'Day 0 to 1', 'description': 'Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported. All tests will be two sided and p-values less than 0.05 will be considered statistically significant.'}, {'measure': 'Incidence of Adverse Events surgery', 'timeFrame': 'From study enrollment up to 30 days after surgery', 'description': 'Cytalux™ (pafolacianine) will be assessed for safety in children and adolescent patients undergoing by the number and severity of adverse events (AEs), defined as events (serious or non-serious) of scientific and medical concern specific to the investigational product and/or the combination of products being used in a study. AEs will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Malignant Solid Neoplasm', 'Childhood Malignant Thoracic Neoplasm', 'Malignant Abdominal Neoplasm', 'Malignant Neck Neoplasm', 'Malignant Pelvic Neoplasm', 'Metastatic Childhood Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This phase III trial studies how well pafolacianine works for identifying cancerous lesions in children and adolescent patients with primary solid tumors or solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Pafolacianine is a fluorescent imaging agent that targets folate receptors which are overexpressed in many cancers and is used with near infrared (NIR) imaging during surgery to identify tumor cells. NIR uses a special camera that uses wavelengths in the infrared range to visualize and locate the tumor cells that are lit up by the pafolacianine. Giving pafolacianine for NIR imaging may work better than other imaging agents in identifying cancerous lesions in pediatric patients with solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness of research participant or legal guardian/representative to give written informed consent\n* Age 6 months to 17 years\n* Have a diagnosis, or a high clinical suspicion, of a solid tumor in the neck, chest, abdomen, pelvis, or extremities with a plan for surgical resection including embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, germ cell tumors. Children may undergo surgical resection or biopsy of a solid tumor that is suspected to be malignant without a separate preoperative biopsy; therefore, the tumor type may not be definitively known preoperatively\n\nExclusion Criteria:\n\n* Previous exposure to Cytalux™ (pafolacianine) injection\n* Any medical condition that in the judgement of the investigators could potentially jeopardize the safety of the participant\n* History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Participants with a medical history of 'idiopathic anaphylaxis' will require evaluation\n* History of allergy to any of the components of Cytalux™ (pafolacianine) injection\n* Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n* Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug. Investigational trials involving administration of drugs or vaccines which are already Food and Drug Administration (FDA)-approved, such as Children's Oncology Group cooperative trials, are okay\n* Known sensitivity to fluorescent light\n* Pregnancy\n* Unable or unwilling to discontinue folic acid, folate supplements, and multi-vitamins containing folate 48 hours prior to drug administration\n* Renal failure on dialysis or estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.72m\\^2 as measured by the U25 eGFR equation for patients ≥1 year(s) of age. For patients \\< 1 year of age, creatinine \\> 2x the upper limit of normal will serve as an exclusion criteria. Creatinine will be measured by enzymatic assay with calibration traceable to the international standard reference materials and minimal bias compared to isotope-dilution mass spectrometry (IDMS) reference methodology.\n* Undergoing workup for liver failure or listed for liver transplant. Patients with Gilbert's syndrome will be excluded if impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin\n* Unable or unwilling to use adequate birth control/contraceptive measures or abstain from sexual activity for 30 days following the study intervention\n* Anticipated need to donate ova or sperm within 30 days following study intervention"}, 'identificationModule': {'nctId': 'NCT06915727', 'briefTitle': 'An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pafolacianine for Localization of Pediatric Extracranial Solid Tumors', 'orgStudyIdInfo': {'id': 'MC250701'}, 'secondaryIdInfos': [{'id': 'NCI-2025-02149', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '24-012249', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}, {'id': 'MC250701', 'type': 'OTHER', 'domain': 'Mayo Clinic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (pafolacianine + NIR)', 'description': 'Patients receive pafolacianine IV over 60 to 90 minutes and undergo NIR fluorescent imaging during standard of care (SOC) surgery on study. Patients also undergo collection of tissue during SOC surgery on study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Near Infrared Imaging', 'Drug: Pafolacianine Sodium', 'Procedure: Surgical Procedure']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo tissue sample collection', 'armGroupLabels': ['Diagnostic (pafolacianine + NIR)']}, {'name': 'Near Infrared Imaging', 'type': 'PROCEDURE', 'otherNames': ['Near-Infrared Imaging', 'NIR Imaging'], 'description': 'Undergo NIR fluorescent imaging', 'armGroupLabels': ['Diagnostic (pafolacianine + NIR)']}, {'name': 'Pafolacianine Sodium', 'type': 'DRUG', 'otherNames': ['Cytalux'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (pafolacianine + NIR)']}, {'name': 'Surgical Procedure', 'type': 'PROCEDURE', 'otherNames': ['Operation', 'Surgery', 'Surgery Type', 'Surgery, Not Otherwise Specified (NOS)', 'Surgical', 'Surgical Intervention', 'Surgical Interventions', 'Surgical Procedures', 'Type of Surgery', 'Surgery, NOS'], 'description': 'Undergo SOC surgery', 'armGroupLabels': ['Diagnostic (pafolacianine + NIR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gina Lewis', 'role': 'CONTACT', 'email': 'DOSCRO2@mayo.edu', 'phone': '507-284-0850'}, {'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Stephanie F. Polites, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Gina Lewis', 'role': 'CONTACT', 'email': 'DOSCRO2@mayo.edu', 'phone': '507-284-0850'}], 'overallOfficials': [{'name': 'Stephanie F. Polites, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}