MR 7700 Multinuclear Application Clinical Trial

January 20, 2026 updated by: Philips Clinical & Medical Affairs Global

MR 7700 Multinuclear Application Clinical Study

The purpose of this clinical trial is to use the medical magnetic resonance imaging system MR 7700 to perform phosphorus (31P) and sodium (23Na) scanning imaging on the human body, evaluate the image quality of phosphorus (31P) and sodium (23Na) scanning, as well as the machine convenience, machine stability, and system safety of the entire system.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • 18 ≤ Age ≤ 75 years old;

    • Clear mind, able to cooperate, and capable of autonomous behavior;
    • Voluntarily agree to participate in this clinical trial and sign the informed consent form for the subjects

Exclusion Criteria:

  • • Individuals with claustrophobia.

    • On the day of scanning, the subject's body temperature was above 39.5 ℃.
    • Plan to become pregnant, pregnant, and breastfeeding women within 6 months.
    • Other implants, prostheses, foreign bodies, patches, etc. that are not suitable for magnetic resonance imaging examination; There are electronic implants such as pacemakers, stimulators, insulin pumps, cochlear implants, etc.
    • Critical patients equipped with various rescue devices, as well as subjects with any emergency medical conditions requiring first aid.
    • Subjects with poor compliance, which the researchers believe should be excluded.
    • Other situations that the investigators believe are not suitable for participating in this experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Device: MR Scanning with Phosphorus nucleus + Sodium nucleus
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Experimental: Patient
Device: MR Scanning with Phosphorus nucleus + Sodium nucleus
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The excellent and good rate of Spectral image quality of 31P-MRS
Time Frame: 14 days (anticipated) after finishing 31P-MRS scanning

Spectral image quality of phosphorus nucleus (31P) in each site (muscle, liver, heart)，will be assessed by Likert score (1-5) .

The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.
14 days (anticipated) after finishing 31P-MRS scanning
The excellent and good rate of image quality of 23Na-MRI
Time Frame: 14 days (anticipated) after finishing 23Na-MRI scanning
Image quality of sodium nuclei (23Na) in each site (liver, cartilage), will be assessed by Likert score (1-5) . The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.
14 days (anticipated) after finishing 23Na-MRI scanning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Device convenience of the entire system
Time Frame: 14 days (anticipated) after finishing scanning

A three-scale assessment will be used for evaluate the device convenience of the entire system from the aspects of subject positioning, scanning interface, scanning sequence, image processing, microphone communication, and image storage/transmission and management.

A three-scale criteria- Satisfied, General, Dissatisfied Assessment criteria: The parameters should all reach "General or Satisfied", indicating that the case meet the device convenience.
14 days (anticipated) after finishing scanning
Device stability
Time Frame: 14 days (anticipated) after finishing scanning

Evaluate the stability of the device from the aspects of system startup, system shutdown, abnormal interruption during scanning, image display after scanning, and missing image reconstruction.

A three-scale criteria- Satisfied, General, Dissatisfied. Assessment criteria: The parameters should all reach "General or Satisfied", indicating that the case meet the device stability.
14 days (anticipated) after finishing scanning
System security
Time Frame: 14 days (anticipated) after finishing scanning
The technician observes whether there are any system safety issues during the scanning of each image instance After the scan, a "yes" or "no" judgment is made based on the occurrence of each assessment item. If all assessment items are rated as "none", it indicates that the system is safe.
14 days (anticipated) after finishing scanning
Adverse event
Time Frame: From the time the subjects signed the ICF to completion of study visit(1 day).
Analyze the adverse events during the clinical trial process, summarize and analyze the frequency and percentage of all adverse events (including serious adverse events) in a list, and classify them based on their correlation with the device.
From the time the subjects signed the ICF to completion of study visit(1 day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 300957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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