None
Conditions
Interventions
Single group (experimental group):Blood biochemical examination
Female urine pregnancy test
MRI scan
User evaluation the device performance
Doctors evaluates the image quality
Doctors evaluate advance
Sponsors
Qilu Hospital of Shandong University(Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, with the ability to act autonomously; 2. Agree to participate in this clinical trial and sign the informed consent; 3. For using MRI contrast agent, the following inclusion items is added to the above inclusion criteria: Those who clinical trial investigators believe require enhanced magnetic resonance imaging scans.
Exclusion criteria
Exclusion criteria: Any subject meeting any of the following exclusion criteria is excluded: Those with electronic implants, such as cardiac pacemakers, neurostimulators, insulin pumps, cochlear implants, etc.; Those who have undergone aneurysm surgery and have intracranial aneurysm clips; Those who have undergone heart surgery and have artificial heart valves; Those with metallic foreign bodies in the eyes; Those with metallic implants and prostheses, or with metallic foreign bodies in other parts of the body; Pregnant women or those planning to become pregnant within three months, as well as nursing mothers; Critically ill patients requiring life support systems; Patients with epilepsy and mental illness; Patients with claustrophobia; Patients with severe cardiovascular diseases, such as those with heart failure, etc.; Any other conditions deemed unsuitable for participation in this trial by the clinical trial researchers; For subjects undergoing contrast-enhanced magnetic resonance imaging, the following additional exclusion criteria are added to the above subject exclusion criteria: Those with a history of contrast agent allergy, bronchial asthma, or other allergic diseases; Those using beta-blockers; Those with severe renal insufficiency, i.e., eGFR < 30 mL/(min*1.73m^2), using the CKD-EPI calculation formula: eGFR = a * (Scr/b)^c * (0.993)^age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image quality excellent rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stability of device functions;Image quality of advance application functions; | — |
Countries
China
Contacts
Public ContactXiangshui.Meng
Qilu Hospital of Shandong University(Qingdao)
Outcome results
None listed