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Calibration of MR and PET-MR Imaging Protocols at RIC

Primary Purpose

Cancer, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-MR imaging on Biograph mMR scanner
MR-only imaging on Biograph mMR scanner
MR imaging on the Siemens Vida 3T MR scanner
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer focused on measuring Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET, PET-MR, mMR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

PET-MR imaging on Biograph mMR scanner

MR-only imaging on Biograph mMR scanner

MR imaging on the Siemens Vida 3T MR scanner

Arm 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.

Participants will undergo research MR-only imaging on Biograph mMR scanner.

Participants will undergo research MR imaging on the Siemens MR scanner

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2014
Last Updated
March 7, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02249520
Brief Title
Calibration of MR and PET-MR Imaging Protocols at RIC
Official Title
Calibration of MR and PET-MR Imaging Protocols at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2040 (Anticipated)
Study Completion Date
December 2040 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. MR-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. MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will build clinical protocols in the future

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Coronary Artery Disease
Keywords
Magnetic Resonance Imaging, MRI, Positron Emission Tomography, PET, PET-MR, mMR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET-MR imaging on Biograph mMR scanner
Arm Type
Other
Arm 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.
Arm Title
MR-only imaging on Biograph mMR scanner
Arm Type
Other
Arm Description
Participants will undergo research MR-only imaging on Biograph mMR scanner.
Arm Title
MR imaging on the Siemens Vida 3T MR scanner
Arm Type
Other
Arm Description
Participants will undergo research MR imaging on the Siemens MR scanner
Intervention Type
Other
Intervention Name(s)
PET-MR imaging on Biograph mMR scanner
Other Intervention Name(s)
Siemens Biograph mMR, molecular imaging, PET-MR, mMR
Intervention 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.
Intervention Type
Other
Intervention Name(s)
MR-only imaging on Biograph mMR scanner
Other Intervention Name(s)
Siemens Biograph mMR, PET-MR
Intervention 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.
Intervention Type
Other
Intervention Name(s)
MR imaging on the Siemens Vida 3T MR scanner
Other Intervention Name(s)
MRI
Intervention Description
Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner
Primary Outcome Measure Information:
Title
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.
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel S. Berman, M.D.
Phone
310 423-4223
Email
bermand@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Rhona Littman
Phone
310 423-4387
Email
littmanr@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S. Berman, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel S. Berman, M.D.

12. IPD Sharing Statement

Learn more about this trial

Calibration of MR and PET-MR Imaging Protocols at RIC

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