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MR 7700 Multinuclear Application Clinical Study

ConditionsHepatocellular CarcinomaMRI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MR Scanning with Phosphorus nucleus + Sodium nucleus

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HCC patientsExperimental treatment 1 intervention
Group B: Healthy volunteersPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days (anticipated)] after finishing 31P-MRS scanning
2

Image quality of 23Na-MRI

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

Time frame
14 days (anticipated)] after finishing 23Na-MRI scanning
3

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)

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philips Clinical & Medical Affairs Global

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: