NCT07368049

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable hepatocellular-carcinoma

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

November 24, 2025

Last Update Submit

January 20, 2026

Conditions

Hepatocellular CarcinomaMRI

Keywords

HCCmultinuclearMRLiver

Outcome Measures

Primary Outcomes (3)

  • Ratio of metabolites （PME/PDE）

    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

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

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

  • Adverse Event

    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).

Study Arms (2)

HCC patients

EXPERIMENTAL

HCC patients

Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Healthy volunteers

PLACEBO COMPARATOR

Healthy volunteers

Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Interventions

MR Scanning with Phosphorus nucleus + Sodium nucleusDEVICE

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

HCC patientsHealthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Fu Hua Yan

CONTACT

(+86)13661850380yfh11655@rjh.com

Andi Gao

CONTACT

(+86)13601250646Andi.Gao@Philips.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

January 26, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01