Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT04306861
Status:
WITHDRAWN
Last Update Posted:
2022-07-21
First Post:
2019-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel MRI Techniques for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC)', 'timeFrame': 'Study Duration, an average of 1 year', 'description': 'Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).'}, {'measure': 'Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC', 'timeFrame': 'Study Duration, an average of 1 year', 'description': 'Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).'}, {'measure': 'Correlate MRI biomarkers with histopathology (the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response).', 'timeFrame': 'Study Duration, an average of 1 year', 'description': 'Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaging', 'MRI', 'PDAC', 'Pancreatic Cancer'], 'conditions': ['Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html', 'label': 'Key Statistics for Pancreatic Cancer'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.', 'detailedDescription': 'Specific Aims\n\n1. To optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC): Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis).\n2. To measure these MRI biomarkers in 20 treatment-naïve patients with biopsy-proven PDAC who have been referred to the Beth Israel Deaconess Medical Center (BIDMC) Pancreatic Cancer Program for neoadjuvant chemo-radiation therapy (CRT).\n3. To correlate these MRI biomarkers with histopathology, i.e. the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response.\n\nThe investigators hypothesize the following:\n\n1. It is feasible to develop dedicated MRI protocols with novel MRI techniques including Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI), and to develop appropriate evaluation methods.\n2. The implementation of these new protocols and evaluation methods in patients with pancreatic ductal adenocarcinoma (PDAC) provide biomarkers which correlate with histology and outcome in treatment-naïve patients.\n3. The biomarkers are also predictive of therapy response in patients with PDAC during neoadjuvant chemo-radiation therapy (CRT) and correlate with the expression of the tumor suppressor gene SMAD4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patient 18 years of age or older;\n* Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC);\n* Patient qualifying for neoadjuvant chemo-radiation therapy;\n* Patient able and willing to participate in the study;\n* Patient must sign the informed consent form in order to participate after the nature of the study has been fully explained to them and any questions they might have are adequately answered.\n* eGFR levels greater than or equal to 30 mL/min/1.73m2 before contrast administration.\n\nExclusion Criteria:\n\n* Patient previously-received or receiving treatment for PDAC at time of enrollment;\n* Inability to understand or follow study instructions\n* Diagnosed by a nutritionist with severe malnutrition;\n* Unintentional weight loss of 20% or more throughout study;\n* BMI of \\< 18.5;\n* Patients with a contraindication to MRI examinations will be excluded from this study.\n* Pregnancy\n* Estimated Glomerular Filtration Rate (eGFR) levels \\< 30 mL/min/1.73m2'}, 'identificationModule': {'nctId': 'NCT04306861', 'briefTitle': 'Novel MRI Techniques for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy', 'orgStudyIdInfo': {'id': '2019-P-000549'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Naïve PDAC Patients', 'description': 'Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.', 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)', 'armGroupLabels': ['Treatment Naïve PDAC Patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Leo L Tsai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Radiology', 'investigatorFullName': 'Leo L Tsai', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}