Study Stopped
Unable to enroll patients
Calibration of MR and PET-MR Imaging Protocols at RIC
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2014
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2040
August 21, 2024
August 1, 2024
26.3 years
September 9, 2014
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
one day
Study Arms (3)
PET-MR imaging on Biograph mMR scanner
OTHERResearch 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.
MR-only imaging on Biograph mMR scanner
OTHERParticipants will undergo research MR-only imaging on Biograph mMR scanner.
MR imaging on the Siemens Vida 3T MR scanner
OTHERParticipants will undergo research MR imaging on the Siemens MR scanner
Interventions
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.
Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.
Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark Taper Foundation Imaging Center at CSMC
- For MR-only calibration: Volunteers who are responding to approved advertising to volunteer at the BIRI Research Imaging Core for research MR
You may not qualify if:
- Age \< 18 years
- Pregnancy
- Any contraindications to MR imaging.
- Any contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S. Berman, M.D.
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator/Chief Cardiac Imaging/Nuclear Cardiology
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 25, 2014
Study Start
September 1, 2014
Primary Completion (Estimated)
December 1, 2040
Study Completion (Estimated)
December 1, 2040
Last Updated
August 21, 2024
Record last verified: 2024-08