Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02249520
Status:
WITHDRAWN
Last Update Posted:
2024-08-21
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calibration of MR and PET-MR Imaging Protocols at RIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057054', 'term': 'Molecular Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to enroll patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of measures of organ uptake, maximum target-to-background ratio and maximum standard uptake value as standard with FDG PET for maximum image quality for all standard protocols.', 'timeFrame': 'one day', 'description': 'The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. Results obtained from these tests will not be analyzed towards the end point of any study and will solely be used to finalize and calibrate the technical performance of the new scanner. All scans will be visually assessed for technique calibration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging', 'MRI', 'Positron Emission Tomography', 'PET', 'PET-MR', 'mMR'], 'conditions': ['Cancer', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner and will be clinically licensed within a short time.', 'detailedDescription': 'PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To avoid administering radioisotope solely for the purposes of this calibration, we will recruit 20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at CSMC who are already receiving an isotope dose for their standard-of-care examination and are willing to be scanned at the Research Imaging Core on the same day right after their clinical exam. Subjects who are having a PET-MR after receiving FDG will have the same body part scanned as they did for clinical testing.\n\nMR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20 volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope involved. Those volunteers who are participating in the MR-only scan will have major body parts and organs scanned as needed for calibration.\n\nMR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will build clinical protocols in the future'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark Taper Foundation Imaging Center at CSMC\n* For MR-only calibration: Volunteers who are responding to approved advertising to volunteer at the BIRI Research Imaging Core for research MR\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnancy\n* Any contraindications to MR imaging.\n* Any contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia.'}, 'identificationModule': {'nctId': 'NCT02249520', 'briefTitle': 'Calibration of MR and PET-MR Imaging Protocols at RIC', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Calibration of MR and PET-MR Imaging Protocols at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core', 'orgStudyIdInfo': {'id': '35521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PET-MR imaging on Biograph mMR scanner', 'description': 'Research PET-MR imaging on Biograph mMR scanner will be conducted immediately following administration of FDG for clinically approved scan. No additional radioisotope will be administered for the research scan.', 'interventionNames': ['Other: PET-MR imaging on Biograph mMR scanner']}, {'type': 'OTHER', 'label': 'MR-only imaging on Biograph mMR scanner', 'description': 'Participants will undergo research MR-only imaging on Biograph mMR scanner.', 'interventionNames': ['Other: MR-only imaging on Biograph mMR scanner']}, {'type': 'OTHER', 'label': 'MR imaging on the Siemens Vida 3T MR scanner', 'description': 'Participants will undergo research MR imaging on the Siemens MR scanner', 'interventionNames': ['Other: MR imaging on the Siemens Vida 3T MR scanner']}], 'interventions': [{'name': 'PET-MR imaging on Biograph mMR scanner', 'type': 'OTHER', 'otherNames': ['Siemens Biograph mMR', 'molecular imaging', 'PET-MR', 'mMR'], 'description': 'Participants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope.', 'armGroupLabels': ['PET-MR imaging on Biograph mMR scanner']}, {'name': 'MR-only imaging on Biograph mMR scanner', 'type': 'OTHER', 'otherNames': ['Siemens Biograph mMR', 'PET-MR'], 'description': 'Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.', 'armGroupLabels': ['MR-only imaging on Biograph mMR scanner']}, {'name': 'MR imaging on the Siemens Vida 3T MR scanner', 'type': 'OTHER', 'otherNames': ['MRI'], 'description': 'Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner', 'armGroupLabels': ['MR imaging on the Siemens Vida 3T MR scanner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Daniel S. Berman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator/Chief Cardiac Imaging/Nuclear Cardiology', 'investigatorFullName': 'Daniel S. Berman', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}