MR 7700 Multinuclear Application Clinical Study

Philips

Status: Not yet enrolling

Conditions: MRI; Hepatocellular Carcinoma

Treatments: Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Study type: Interventional

Funder types: Industry

Identifiers

NCT07368049

301455

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

HCC patients

Experimental group

Description:

HCC patients

Treatment:

Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Healthy volunteers

Placebo Comparator group

Description:

Healthy volunteers

Treatment:

Device: MR Scanning with Phosphorus nucleus + Sodium nucleus