Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 10:22 AM
Study NCT ID:
NCT06204159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2024-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Exploratory'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2024-01-03', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volume and density of lipiodol', 'timeFrame': 'immediately following TACE', 'description': 'To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TACE', 'Catheter'], 'conditions': ['Hepatocellular Carcinoma', 'Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.\n\n• Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?\n\nParticipants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.', 'detailedDescription': 'Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged \\>18 years.\n* Plan to undergo lipiodol TACE for HCC or NET liver metastases\n* Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned\n* Liver tumor burden does not exceed 50% of the liver volume\n* Patent main portal vein\n* Life expectancy of greater than 6 months\n* ECOG performance status 0-2\n* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl\n* Adequate marrow and renal function as defined as:\n* Platelets \\>75,000/mcL (may be corrected by transfusion)\n* Serum creatinine \\< 2.0 mg/dl\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.\n* Provision of signed and dated informed consent form and ability to consent for oneself.\n* Stated willingness to comply with all study procedures and availability for the study duration.\n\nExclusion Criteria:\n\n* Absolute contraindication to contrast-enhanced MRI\n* Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication\n* Pregnancy or lactation\n* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT06204159', 'acronym': 'Trinav', 'briefTitle': 'Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery', 'orgStudyIdInfo': {'id': 'UPCC 01223'}, 'secondaryIdInfos': [{'id': '853163', 'type': 'OTHER', 'domain': 'University of Pennsylvania IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'End Hole Catheter followed by TriNav Catheter', 'description': 'FDA approved catheter\n\nRandomization End Hole catheter then TriNav catheter', 'interventionNames': ['Device: TACE Catheters']}, {'type': 'EXPERIMENTAL', 'label': 'TriNav Catheter followed by End Hole Catheter', 'description': 'FDA approved catheter\n\nRandomization TriNav catheter then End Hold catheter', 'interventionNames': ['Device: TACE Catheters']}], 'interventions': [{'name': 'TACE Catheters', 'type': 'DEVICE', 'description': 'End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure.\n\nThis study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure', 'armGroupLabels': ['End Hole Catheter followed by TriNav Catheter', 'TriNav Catheter followed by End Hole Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania, Department of Radiology, Interventional Radiology Division', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'TriSalus Life Sciences, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}