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NCT Number: NCT07368049

MR 7700 Multinuclear Application Clinical Study

The purpose of this clinical study is to perform phosphorus nucleus (31P) and sodium nucleus (23Na) imaging of the liver in patients with primary hepatocellular carcinoma (HCC) and healthy volunteers using the MR 7700 Magnetic Resonance Equipment, in order to explore the manifestations of multinuclear imaging in HCC patients and healthy volunteers.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. HCC patient group
  • Age ≥ 18 years;
  • With clear consciousness, ability to cooperate, and autonomous behavior;
  • Voluntary agreement to participate in this clinical trial and signing of the subject's informed consent form;
  • Patients diagnosed with primary hepatocellular carcinoma by imaging or clinical diagnosis, and who have not received tumor treatment.
  • 2. Healthy control group
  • Age ≥ 18 years;
  • With clear consciousness, ability to cooperate, and autonomous behavior;
  • Voluntary agreement to participate in this clinical trial and signing of the subject's informed consent form;
  • No previous history of liver disease.

Exclusion criteria

  • HCC patient group and healthy control group
  • Patients with claustrophobia.
  • Subject's body temperature > 39.5°C on the day of scanning.
  • Females who plan to be pregnant within 6 months, and pregnant and lactating females.
  • Patients with other implants, prostheses, foreign bodies, patches, etc. that are not suitable for MRI examination; patients with electronic implants, such as pacemakers, stimulators, insulin pumps, cochlear implants, etc.
  • Critically ill subjects with various resuscitation devices or those with any emergency medical condition requiring first aid.
  • Subjects with poor compliance are considered to be excluded by the investigators.
  • Subjects who are not considered suitable for this trial by the investigators.

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. Ratio of metabolites (PME/PDE)

    Time frame: 14 days (anticipated)] after finishing 31P-MRS scanning

    By comparing the ratios of metabolites (PME/PDE) in the liver, the effectiveness of 31P magnetic resonance spectroscopy (31P-MRS) was evaluated.

    Theoretically,the PME/PDE ratio in patients with HCC was higher than that in healthy volunteers.

  2. Image quality of 23Na-MRI

    Time frame: 14 days (anticipated)] after finishing 23Na-MRI scanning

    Image quality will be assessed by Likert score (1-5)

  3. Adverse Event

    Time frame: From the time the subjects signed the ICF to completion of study visit(1 day).

    Monitor adverse events and serious adverse events during the study,summarize and analyze the frequency and percentage of all adverse events (including severe adverse events)

Study contacts

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

Andi Gao

CONTACT

[email protected]

(+86)13601250646

Fu Hua Yan

CONTACT

[email protected]

(+86)13661850380

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

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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