Clinical TrialID 8220
Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
NCT05687864
Magnetic Resonance Imaging|Chronic Kidney Diseases
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8220
- Evidence Id
- 8220
- Core Evidence Id
- 8220
- Source Clinical Trial Id
- 8218
- Herb2 Clinical Trial Id
- HBCT008218
- Nct Id
- NCT05687864
- Title
- Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
- Status
- Recruiting
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Magnetic Resonance Imaging|Chronic Kidney Diseases
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
- Intervention
- DIAGNOSTIC_TEST: Polysaccharide superparamagnetic ferric oxide injection
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Diagnostic
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 30
- Outcome Measure
- Signal-to-Noise Ratio (SNR), On the basis of vascular segments, the signal-to-noise ratio at different doses and time points was calculated by magnetic resonance imaging., Before administration, 5minutes, 24 hours, 48 hours after administration|Contrast to noise ratio (CNR), On the basis of vascular segments, the Contrast to noise ratio at different doses and time points was calculated by magnetic resonance imaging., Before administration, 5minutes, 24 hours, 48 hours after administration|Image quality score before administration, On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate., Before administration|Image quality score at 5 minutes, On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate., 5 minutes after administration|Image quality score at 24 hours, On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate., 24 hours after administration|Image quality score at 48 hours, On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate., 48 hours after administration
- Sponsor Collaborator
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Funded By
- INDUSTRY
- Location
- Beijing Chaoyang Hospital, Capital Medical University, Beijing, Beijing, 100020, China
- Other Id
- DJTCSCYHT-I-04
- Start Date
- 2023-06-17
- Primary Completion Date
- 2023-12
- Completion Date
- 2023-12
- First Posted
- 2023-01-18
- Results First Posted
- Last Update Posted
- 2023-06-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05687864
- Title Cn
- Title En
- Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
- Bilingual Status
- semi_complete