Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-11 @ 11:33 PM
Study NCT ID:
NCT02682394
Status:
UNKNOWN
Last Update Posted:
2016-02-15
First Post:
2015-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cell-free DNA, CFD'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-12', 'studyFirstSubmitDate': '2015-12-28', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area.', 'timeFrame': 'at 24 hours before chemotherapy starting', 'description': 'measuring Pancreatic Steatosis in patients with pancreatic cancer using MRI DIXON scan, at 24 hours before chemotherapy starting.'}, {'measure': 'Blood levels of free DNA', 'timeFrame': 'The blood sample taken 15 minutes prior to MRI study, at time of IV access.', 'description': 'Correlation of free DNA level and metastatic spread.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer of pancreas', 'steatosis', 'MRI'], 'conditions': ['Cancer of Pancreas']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.health.gov.il/UnitsOffice/HD/ICDC/ICR/CancerIncidence/Pages/default.aspx', 'label': 'Ministry of Health, Israel. Israel Cancer Registry.'}]}, 'descriptionModule': {'briefSummary': 'Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer', 'detailedDescription': '1. Finding patients with pancreatic cancer (in all stages), before any treatment.\n2. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.\n3. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.\n4. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with any pancreatic cancer, in any stage, before treatment.\n* \\>18 y.o\n\nExclusion Criteria:\n\n* claustrophobia\n* GFR\\<30\n* patients with non mri compatible devices (e.g. orthopaedic external fixation system)\n* After chemotherapy treatment or surgical procedure'}, 'identificationModule': {'nctId': 'NCT02682394', 'briefTitle': 'Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients With Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'SOR0216-15CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Vladimir Borodetsky, MD', 'role': 'CONTACT', 'email': 'zivova1982@gmail.com', 'phone': '+972547428882'}, {'name': 'Irina Lazerev, MD', 'role': 'CONTACT', 'email': 'irinalaz@clalit.org.il', 'phone': '+972526226458'}, {'name': 'Alla Khashper, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka university medical center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Vladimir Borodetsky, MD', 'role': 'CONTACT', 'email': 'zivova1982@gmail.com', 'phone': '+972547428882'}, {'name': 'Irena Lazerev, MD', 'role': 'CONTACT', 'email': 'irinalaz@clalit.org.il', 'phone': '+972526226458'}], 'overallOfficials': [{'name': 'Alla Khashper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}