Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-05 @ 6:35 PM
Study NCT ID:
NCT02761356
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2016-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Y-90 SIRT for Liver Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C038216', 'term': 'technetium Tc 99m-Sn aggregated albumin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2016-02-11', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual assesment of Tc-99m-MAA in liver lesions compared to visual assesment of Y-90 sirtex.', 'timeFrame': 'one year', 'description': 'Undestanding the role of Tc-99- MAA in the prediction of Y90 sirt uptake in liver lesions by visual assesment with PET-CT and SPECT-CT imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Liver Tumor, Metastatic Liver']}, 'descriptionModule': {'briefSummary': 'Patients cohort is composed of 50 consecutive patients both male and female with hepatic malignancies, refered to our nuclear medicine department in the process of radioembolization between January 2010- August 2015. 26 of the patients were examined with Tc99-MAA and SPECT-CT and 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Our study protocol was as follows:\n\n1. Collection of anamnestic data\n2. Calculation of liver tumor volume with quantification software\n3. Evaluation of the liver tumor involvement\n4. Evaluation of liver to lung shunt\n5. Calculation dose of SIRTEX\n6. Y90 imaging\n7. Follow Up', 'detailedDescription': "The description of the various stages that the patient goes through SIRTex treatment in the department of nuclear medicine and their roll in the study is as following:\n\nThe first stage is dedicated to the evaluation of the patient's illegibility for the treatment.\n\n1. In Angiography department\n2. In Nuclear medicine department assessment of liver-lung shunting (planar images). Followed by SPECT-CT of the upper abdomen. SPECT with Low dose CT is used to identify a leak to the stomach, duodenum and mesentery, as well as to assess uptake of Tc-99m-MAA in tumor lesions. In order to increase SPECT-CT resolution and sensitivity we co-registrated SPECT-CT with diagnostic CT provided from previous contrast enhanced CT or PET-CT. In this procedure, the Low dose CT is used as bridge between diagnostic CT and the functional imaging SPECT.\n3. Calculation dose of Sirtex therapy. At this stage the purpose of the study will be to investigate the added value of SPECT-CT in the estimation of Tc-99m-MAA uptake in tumor lesions.\n\nThe second stage is dedicated to the assessment Y-90-SIRTex uptake in liver tumors and to exclude extra hepatic leak. Several hours after treatment patients perform SPECT-CT using Brummshtrullung emission or PET-CT with the peak Zr-90.\n\nAt this stage , in our study, we will compare liver lesions uptake of Tc-99m-MAA in the SPECT-CT to lesions uptake of Y-90 -SIRT SPECT/PET-CT as well as to assess if SPECT-CT withTc-99m-MAA may be used as a predictor of Y-90-SIRTex uptake in liver lesion. Does SPECT-CT with Tc-99m-MAA change patient managment.\n\nThe third stage of the study is the collection and monitoring of post treatment outcome data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated with Yttrium-90 SIRT for liver malignancies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age ≥ 18. 2. Patients with malignancy of the liver (metastasis or primary tumor) who were treated with Y90 SIRT and were refered to the nuclear medicine department for a PET-CT.\n\nExclusion Criteria:\n\n* 1\\. Age \\< 18. 2. Pregnant woman 3. Children and legally incompetent.'}, 'identificationModule': {'nctId': 'NCT02761356', 'briefTitle': 'The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Y-90 SIRT for Liver Malignancies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Yttrium-90 SIRT for Liver', 'orgStudyIdInfo': {'id': 'TASMC-16-ES-0413-15-TLV-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tc99-MAA and SPECT-CT', 'description': '26 of the patients were examined with Tc99-MAA and SPECT-C', 'interventionNames': ['Other: Tc99-MAA']}, {'label': 'Tc99-MAA , SPECT-CT and PET-CT', 'description': '24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT.', 'interventionNames': ['Other: Tc99-MAA']}], 'interventions': [{'name': 'Tc99-MAA', 'type': 'OTHER', 'otherNames': ['Tc-99m-macroaggregated albumin'], 'description': 'To evaluate the fisibility of Tc99-MAA injected intra epatic artery to predict uptake of Yttrium-90 SIRT in patients with liver malignancies', 'armGroupLabels': ['Tc99-MAA , SPECT-CT and PET-CT', 'Tc99-MAA and SPECT-CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Einat Even-Sapir, Phd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}