Calibration of MR and PET-MR Imaging Protocols at RIC

Cedars-Sinai Medical Center

Status: Withdrawn

Conditions: Coronary Artery Disease; Cancer

Treatments: Other: MR-only imaging on Biograph mMR scanner; Other: PET-MR imaging on Biograph mMR scanner; Other: MR imaging on the Siemens Vida 3T MR scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT02249520

35521

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

PET-MR imaging on Biograph mMR scanner

Other group

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.

Treatment:

Other: PET-MR imaging on Biograph mMR scanner

MR-only imaging on Biograph mMR scanner

Other group

Description:

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

Treatment:

Other: MR-only imaging on Biograph mMR scanner

MR imaging on the Siemens Vida 3T MR scanner

Other group

Description:

Participants will undergo research MR imaging on the Siemens MR scanner

Treatment:

Other: MR imaging on the Siemens Vida 3T MR scanner