Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-04-05 @ 11:59 AM
Study NCT ID:
NCT02429804
Status:
TERMINATED
Last Update Posted:
2017-05-30
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Accrual factor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2015-04-17', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity', 'timeFrame': '24 weeks', 'description': 'Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.'}, {'measure': 'Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size', 'timeFrame': '24 weeks', 'description': 'Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.'}, {'measure': 'Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis)', 'timeFrame': '24 weeks', 'description': 'Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.'}, {'measure': 'Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value', 'timeFrame': '12 weeks'}, {'measure': 'Percent reduction at 12 weeks in MRI lesion size (per lesion analysis)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis)', 'timeFrame': '12 months', 'description': 'The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hormone-Resistant Prostate Cancer', 'Metastatic Malignant Neoplasm in the Bone', 'Metastatic Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Estimate the performance of simultaneous NaF/FDG PET/MRI for the prediction of treatment response in patients with metastatic castrate resistant prostate cancer (mCRPC).\n\nII. Estimate the performance of simultaneous NaF/FDG PET/MRI for detection of extra-skeletal disease progression during treatment in mCRPC patients.\n\nOUTLINE:\n\nPatients receive 18F NaF and 18F FDG intravenously (IV) over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.\n\nAfter completion of study, patients are followed up for up to 12 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provides written informed consent\n* Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride)\n* Able to remain still for duration of the imaging procedure (about one hour)\n\nExclusion Criteria:\n\n* Metallic implants'}, 'identificationModule': {'nctId': 'NCT02429804', 'briefTitle': 'NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study', 'orgStudyIdInfo': {'id': 'PROS0063'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00553', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ep 32653'}, {'id': '96754'}, {'id': 'PROS0063', 'type': 'OTHER', 'domain': 'Stanford University Hospitals and Clinics'}, {'id': 'P30CA124435', 'link': 'https://reporter.nih.gov/quickSearch/P30CA124435', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)', 'description': 'Patients receive 18F NaF and 18F FDG IV over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.', 'interventionNames': ['Procedure: Contrast-enhanced Magnetic Resonance Imaging', 'Drug: Fludeoxyglucose F-18', 'Drug: Fluorine F 18 Sodium Fluoride', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Contrast-enhanced Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['CONTRAST ENHANCED MRI', 'Contrast-enhanced MRI'], 'description': 'Undergo contrast-enhanced MRI', 'armGroupLabels': ['Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)']}, {'name': 'Fludeoxyglucose F-18', 'type': 'DRUG', 'otherNames': ['18FDG', 'FDG', 'fludeoxyglucose F 18', 'Fludeoxyglucose F18', 'Fluorine-18 2-Fluoro-2-deoxy-D-Glucose', 'Fluorodeoxyglucose F18'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)']}, {'name': 'Fluorine F 18 Sodium Fluoride', 'type': 'DRUG', 'otherNames': ['18 F-NaF', 'F-18 NaF'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo PET/MRI', 'armGroupLabels': ['Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET SCAN', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo PET/MRI', 'armGroupLabels': ['Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andrei Iagaru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Andrei Iagaru', 'investigatorAffiliation': 'Stanford University'}}}}