MR 7700 Multinuclear Application Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR Scanning with Phosphorus nucleus + Sodium nucleus.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, MRI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device MR Scanning with Phosphorus nucleus + Sodium nucleus
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Primary outcome measures
- Ratio of metabolites （PME/PDE） [Time frame: 14 days (anticipated)] after finishing 31P-MRS scanning]
- Image quality of 23Na-MRI [Time frame: 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07368049 · 301455