Calibration of MR and PET-MR Imaging Protocols at RIC

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02249520
• Other study ID #: 35521
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2040

Study information

• Verified date: March 2022
• Source: Cedars-Sinai Medical Center
• Contact: Daniel S. Berman, M.D.
• Phone: 310 423-4223
• Email: bermand[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Coronary Artery Disease

Intervention

Other:
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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