Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 2:41 PM
Study NCT ID:
NCT03996850
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPECT/CT for the Characterization of Renal Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D014965', 'term': 'X-Rays'}, {'id': 'D017785', 'term': 'Photons'}, {'id': 'D017256', 'term': 'Technetium Tc 99m Sestamibi'}], 'ancestors': [{'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'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015609', 'term': 'Organotechnetium Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient management decision', 'timeFrame': '6 months', 'description': 'Assessed with post-test, physician counseling.'}], 'secondaryOutcomes': [{'measure': 'Decision making based on tumor size', 'timeFrame': '6 months', 'description': 'Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Neoplasm', 'Renal Mass']}, 'descriptionModule': {'briefSummary': 'This trial studies how well technetium Tc-99m sestamibi single-photon emission computed tomography/computed tomography (SPECT/CT) works on clinical decision making in patients with kidney tumors. Diagnostic procedures, such as technetium Tc-99m sestamibi SPECT/CT may be a less invasive way to check for kidney tumors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the impact of MIBI SPECT/CT on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm.\n\nII. To assess the impact of MIBI SPECT/CT on decisional conflict score. III. To assess the impact of MIBI SPECT/CT on physician management recommendation.\n\nIV. To evaluate the sensitivity and specificity of MIBI SPECT/CT for the identification of an oncocytic renal mass (oncocytoma, chromophobe, and hybrid oncocytic tumor) with respect to tumor histology identified by renal mass biopsy or surgical resection.\n\nV. To compare the specificity of MIBI SPECT/CT with conventional cross-sectional imaging in predicting an oncocytic renal mass.\n\nVI. To assess the correlation between MIBI SPECT/CT outcomes to final treatment decisions.\n\nEXPLORATORY OBJECTIVES:\n\nI. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.\n\nOUTLINE:\n\nPatients receive technetium Tc-99m sestamibi intravenously (IV) then undergo SPECT/CT.\n\nAfter completion of study, patients are followed up for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with new diagnosis of a renal tumor (within past 3 months)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performance status Eastern Cooperative Oncology Group (ECOG) \\< 2.\n* Life expectancy (\\> 1 year).\n* New diagnosis of a renal tumor (within past 3 months).\n* Measurable, predominantly (\\> 80%) solid renal neoplasm between 1.5-5.0 cm.\n* Lesion concerning for kidney cancer bases on a contrast-enhanced CT or magnetic resonance imaging (MRI).\n* No definitive evidence of metastatic disease.\n* Does not require urgent surgical treatment.\n* Candidate for surgical, ablative, and surveillance approach.\n* Willingness to obtain more information to aid decision-making.\n* Understanding and willingness to provide consent.\n\nExclusion Criteria:\n\n* Presence of multiple solid renal tumors.\n* A prior needle biopsy of the mass resulting in histologic diagnosis.\n* A prior diagnosis of kidney cancer.\n* Presence of an active, untreated, non-renal malignancy.\n* History of bleeding diathesis or recent bleeding episode.\n* Prior surgery or radiation therapy to the kidney.\n* Unwillingness to fill out questionnaires.'}, 'identificationModule': {'nctId': 'NCT03996850', 'briefTitle': 'SPECT/CT for the Characterization of Renal Masses', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making', 'orgStudyIdInfo': {'id': '18-001817'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02711', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health service research (MIBI SPECT/CT, questionnaire)', 'description': 'Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.', 'interventionNames': ['Procedure: Computed Tomography', 'Other: Questionnaire Administration', 'Procedure: Single Photon Emission Computed Tomography', 'Radiation: Technetium Tc-99m Sestamibi']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo SPECT/CT', 'armGroupLabels': ['Health service research (MIBI SPECT/CT, questionnaire)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Health service research (MIBI SPECT/CT, questionnaire)']}, {'name': 'Single Photon Emission Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Single Photon Emission Computed Tomography', 'Single Photon Emission Tomography', 'single-photon emission computed tomography', 'SPECT', 'SPECT imaging', 'SPECT SCAN', 'SPET', 'tomography, emission computed, single photon', 'Tomography, Emission-Computed, Single-Photon'], 'description': 'Undergo SPECT/CT', 'armGroupLabels': ['Health service research (MIBI SPECT/CT, questionnaire)']}, {'name': 'Technetium Tc-99m Sestamibi', 'type': 'RADIATION', 'otherNames': ['Cardiolite', 'Miraluma', 'Tc 99m Sestamibi', 'Tc-99m MIBI', 'Tc99m Sestamibi'], 'description': 'Given IV', 'armGroupLabels': ['Health service research (MIBI SPECT/CT, questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Shuch', 'role': 'CONTACT', 'email': 'BShuch@mednet.ucla.edu', 'phone': '310-794-7700'}, {'name': 'Brian Shuch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Brian Shuch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}