Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 12:00 PM
Study NCT ID:
NCT03987568
Status:
WITHDRAWN
Last Update Posted:
2022-12-21
First Post:
2019-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterize Tumor Hypoxia by Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Issues in reserving MRI scanner', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Tumor Hypoxia Scores Between Subgroups', 'timeFrame': '30 days', 'description': "Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient."}, {'measure': 'Number of Biomarkers Expressed', 'timeFrame': '30 days', 'description': "Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient."}], 'secondaryOutcomes': [{'measure': 'ExoHypoxic Concentrations in Plasma', 'timeFrame': '30 days', 'description': "The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted."}, {'measure': 'Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations', 'timeFrame': '30 days', 'description': "The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.', 'detailedDescription': "Primary Objective(s):\n\n* To assess hypoxia in primary prostate tumors by magnetic resonance imaging.\n* To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).\n\nSecondary Objective(s):\n\n* To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.\n* To correlate hypoxic score with fatty acid synthase (FASN) expression."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of 40.\n* Patients with Caucasian and African American race\n* Patients with pathology-proven prostate cancer (Gleason 6 or higher)\n* Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy)\n* Patients who will have a radical prostatectomy as standard of care.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).\n\nExclusion Criteria:\n\n* Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment.\n* Patients with any other cancer along with prostate cancer.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'}, 'identificationModule': {'nctId': 'NCT03987568', 'briefTitle': 'Characterize Tumor Hypoxia by Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'IRB00059037'}, 'secondaryIdInfos': [{'id': 'WFBCCC 03319', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprenhensive Cancer Center'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}, {'id': 'NCI-2019-04690', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (MRI biospecimen collection)', 'description': 'Patients undergo MRI over 15 minutes before standard of care surgery. Patients also undergo collection of blood samples during MRI and at the time of surgery.', 'interventionNames': ['Other: Blood draws', 'Diagnostic Test: Magnetic resonance imaging (MRI)']}], 'interventions': [{'name': 'Blood draws', 'type': 'OTHER', 'description': "Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.", 'armGroupLabels': ['Diagnostic (MRI biospecimen collection)']}, {'name': 'Magnetic resonance imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'At the beginning of study magnetic resonance imaging MRI will be completed.', 'armGroupLabels': ['Diagnostic (MRI biospecimen collection)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gagan Deep, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}