Calibration of MR and PET-MR Imaging Protocols at RIC

NCT ID: NCT02249520

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2040-12-31

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

Conditions

Cancer; Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET-MR imaging on Biograph mMR scanner

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.

Group Type: OTHER

PET-MR imaging on Biograph mMR scanner

Intervention Type: OTHER

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.

MR-only imaging on Biograph mMR scanner

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

Group Type: OTHER

MR-only imaging on Biograph mMR scanner

Intervention Type: OTHER

Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.

MR imaging on the Siemens Vida 3T MR scanner

Participants will undergo research MR imaging on the Siemens MR scanner

Group Type: OTHER

MR imaging on the Siemens Vida 3T MR scanner

Intervention Type: OTHER

Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner

Interventions

PET-MR imaging on Biograph mMR scanner

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

MR-only imaging on Biograph mMR scanner

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

MR imaging on the Siemens Vida 3T MR scanner

Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner

Intervention Type: OTHER

Other Intervention Names

Siemens Biograph mMR; molecular imaging; PET-MR; mMR; Siemens Biograph mMR; PET-MR; MRI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel S. Berman

Principal Investigator/Chief Cardiac Imaging/Nuclear Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S. Berman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

35521

Identifier Type: -

Identifier Source: org_study_id