Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-04 @ 7:13 PM
Study NCT ID:
NCT05641935
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal cell carcinoma recurrence', 'timeFrame': 'Up to 2 years', 'description': 'Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.'}], 'secondaryOutcomes': [{'measure': 'Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion', 'timeFrame': 'Up to 2 years', 'description': 'Contrast-enhanced imaging on all patients will be evaluated by radiologists at each site to determine if it increases the ability to diagnose recurrence compared to standard imaging.'}, {'measure': 'Measurement with multimodality 3D CEUS to improve detection of recurrence', 'timeFrame': 'Up to 2 years', 'description': '3D CEUS imaging will be evaluated by radiologists at each site to determine if it improved detection of recurrence.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Renal Cell Carcinoma', 'Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2D contrast-enhanced ultrasound (CEUS) and contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) for detecting recurrent or residual renal cell carcinoma (RCC) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross sectional imaging.\n\nII. To assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation.\n\nIII. To explore the use of quantitative imaging parameters extracted from 2D/3D CEUS datasets to determine if this improves the overall performance of CEUS.\n\nEXPLORATORY OBJECTIVE:\n\nI. An advanced Doppler technique designed for detection of slower flow will also be investigated as a non-contrast based approach for detecting recurrent disease.\n\nOUTLINE:\n\nPatients receive Lumason intravenously (IV) and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously received cryotherapy or microwave therapy of RCC\n* Has available contrast enhanced (CE)-MRI or CE-CT imaging prior to ablative therapy\n* Have previously had or are scheduled to have a contrast-enhanced MRI/CT for the monitoring of RCC recurrence within 4 weeks of the CEUS study\n* Be at least 18 years of age\n* Be medically stable\n* If a female of child-bearing age, must have a negative pregnancy test\n* Have signed Informed Consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable\n* Patients with known sensitivities to the components of Lumason'}, 'identificationModule': {'nctId': 'NCT05641935', 'briefTitle': 'Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Multi-Modality Detection of RCC Recurrence Post Ablation', 'orgStudyIdInfo': {'id': '22F.825'}, 'secondaryIdInfos': [{'id': 'R01CA269750', 'link': 'https://reporter.nih.gov/quickSearch/R01CA269750', 'type': 'NIH'}, {'id': 'JT 24546', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (CEUS with MRI/CT)', 'description': "Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.", 'interventionNames': ['Drug: Sulfur Hexafluoride Lipid Microspheres', 'Procedure: Contrast-Enhanced Ultrasound', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Other: Electronic Health Record Review']}], 'interventions': [{'name': 'Sulfur Hexafluoride Lipid Microspheres', 'type': 'DRUG', 'otherNames': ['Lumason', 'SF6 Lipid Microspheres', 'Sulfur Hexafluoride Lipid-type A Microspheres'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (CEUS with MRI/CT)']}, {'name': 'Contrast-Enhanced Ultrasound', 'type': 'PROCEDURE', 'otherNames': ['CEUS'], 'description': 'Undergo CEUS', 'armGroupLabels': ['Diagnostic (CEUS with MRI/CT)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'computerized axial tomography', 'Computerized Tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Diagnostic (CEUS with MRI/CT)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging Scan', 'Medical Imaging', 'Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'nuclear magnetic resonance imaging'], 'description': 'Undergo MRI', 'armGroupLabels': ['Diagnostic (CEUS with MRI/CT)']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Review electronic medical record', 'armGroupLabels': ['Diagnostic (CEUS with MRI/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Eisenbrey, MD', 'role': 'CONTACT', 'email': 'john.eisenbrey@jefferson.edu'}], 'facility': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'John Eisenbrey, PhD', 'role': 'CONTACT', 'email': 'john.eisenbrey@jefferson.edu', 'phone': '215-503-5188'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'john eisenbrey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Radiology', 'investigatorFullName': 'john eisenbrey', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}