Hepatocellular Carcinoma, MRI
Conditions
Keywords
HCC, multinuclear, MR, Liver
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.
Interventions
Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of metabolites （PME/PDE） | 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. |
| Image quality of 23Na-MRI | 14 days (anticipated)] after finishing 23Na-MRI scanning | Image quality will be assessed by Likert score (1-5) |
| Adverse Event | 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) |
Contacts
CONTACTFu Hua Yan
CONTACTAndi Gao
Outcome results
None listed