MR 7700 Multinuclear Application Clinical Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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:

  • 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.

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
Placebo Comparator: 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: HCC patients
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
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.
14 days (anticipated)] after finishing 31P-MRS scanning
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)
14 days (anticipated)] after finishing 23Na-MRI scanning
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)
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)

January 5, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 24, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301455

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

product manufactured in and exported from the U.S.

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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