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NCT Number: NCT07368036

MR 7700 Multinuclear Application Clinical Trial

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.

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Key information

Conditions

MR Multinuclear Device Convenience Device Stability Image Quality System Safety

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR Scanning with Phosphorus nucleus + Sodium nucleus

Device

Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning

Primary outcomes

  1. 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%.

  2. 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%.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andi Gao

CONTACT

[email protected]

(+86)13601250646

Bing Zhang

CONTACT

[email protected]

(+86)15851803070

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

MR 7700 Multinuclear Application Clinical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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