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Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging

Primary Purpose

Magnetic Resonance Imaging, Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Polysaccharide superparamagnetic ferric oxide injection
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.; Age: ≥18 years old (at the time of signing the informed consent), gender is not limited; Patients diagnosed with Chronic Kidney Disease (CKD, 2012 KDIGO Guidelines); Eastern Cooperative Oncology Group (ECOG) score 0~1; Expected survival ≥3 months; Serum ferritin ≤ 1000μg/L and transferrin saturation ≤ 50%; The major organs function are good and meet the following criteria: blood routine examination: Hemoglobin ≥ 90g/L Neutrophil count (NEUT) ≥1.5×109/L; Platelet count (PLT) ≥ 75×109/L; Biochemical examination should meet the following standards: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine transferase (ALT), aspartate transferase (AST) and gamma glutamyltransferase (gamma-GGT) ≤ 3ULN; Left ventricular ejection fraction (LVEF) ≥50%. Women of reproductive age should agree to use effective birth control during the study period and for 6 months after the study, and have a negative serum-pregnancy test within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period. Exclusion Criteria: Had or currently have malignant tumors within 3 years. The following three conditions were eligible for inclusion: patients with other malignancies treated with a single operation achieved continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; The disease was stable as assessed by the investigators, and the concomitant drugs did not affect medication during the trial and follow-up period. Subjects with any severe and/or uncontrolled medical conditions, including: Poorly controlled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg) or poorly controlled hypotension (systolic blood pressure <90mmHg or diastolic blood pressure <60 mmHg); Have ≥ grade 2 myocardial ischemia or myocardial infarction and/or severe or malignant arrhythmias [including QTc ≥450ms in men, QTc ≥470ms in women] and/or ≥ grade 2 congestive heart failure [New York Heart Association (NYHA)]; Active infection (≥NCI, CTC AE 5.0, Grade 2); Viral hepatitis, syphilis, HIV and other infectious diseases; A history of immunodeficiency, including acquired or congenital immunodeficiency diseases, or a history of organ transplantation; People who have epilepsy and require treatment. Research and treatment related: Patients with iron deficiency anemia; Subjects who are allergic to intravenous iron preparations, the investigational drug or any of its components, or two or more types of drugs; Subjects who plan to undergo magnetic resonance imaging during the study period and during follow-up. Participants who have participated in other clinical trials of drugs or medical device within 28 days before the start of the study treatment; Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders; Pregnant or lactating women; Patients with non-magnetic compatible metal foreign bodies (false teeth, contraceptive rings, metal implants, metal clips, etc.) and claustrophobia; Patients with difficulty or inability to tolerate MRI scanning; Subjects with concomitant diseases that, in the investigator's judgment, seriously endanger subjects' safety or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.

Sites / Locations

  • Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polysaccharide superparamagnetic ferric oxide injection

Arm Description

Participants will receive one single dose of 1mg/kg or 2mg/kg or 3mg/kg or 4mg/kg or 5mg/kg of Polysaccharide superparamagnetic ferric oxide injection on Day 1.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

T2* value of Liver
T2* signals in the liver were quantitatively detected by magnetic resonance scanning
R2 value of Liver
R2 signals in the liver were quantitatively detected by magnetic resonance scanning
Magnetic sensitivity of brain tissue
Magnetic resonance scanning was used to quantitatively detect magnetic sensitivity of brain tissue
Incidence of adverse events
The incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Incidence of severe adverse events
The incidence of severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Full Information

First Posted
January 5, 2023
Last Updated
June 25, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05687864
Brief Title
Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
Official Title
Single-center, Multiple-strength, Single-dose Phase I Clinical Trial to Evaluate the Effect of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Polysaccharide super paramagnetic ferric oxide injection is an iron supplement developed for patients with iron deficiency anemia. Due to its characteristics, it has the potential to be a contrast agent. The DJTCSCYHT-I-04 study is a single-center, multiple-strength and single-dose phase I clinical study on cardiovascular MRI in patients with chronic kidney disease, aiming to investigate the effects and safety of multi-strength, single-dose at different time points, and to provide reference for clinical diagnosis and MRI enhancement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging, Chronic Kidney Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polysaccharide superparamagnetic ferric oxide injection
Arm Type
Experimental
Arm Description
Participants will receive one single dose of 1mg/kg or 2mg/kg or 3mg/kg or 4mg/kg or 5mg/kg of Polysaccharide superparamagnetic ferric oxide injection on Day 1.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysaccharide superparamagnetic ferric oxide injection
Intervention Description
The polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent
Primary Outcome Measure Information:
Title
Signal-to-Noise Ratio (SNR)
Description
On the basis of vascular segments, the signal-to-noise ratio at different doses and time points was calculated by magnetic resonance imaging.
Time Frame
Before administration, 5minutes, 24 hours, 48 hours after administration
Title
Contrast to noise ratio (CNR)
Description
On the basis of vascular segments, the Contrast to noise ratio at different doses and time points was calculated by magnetic resonance imaging.
Time Frame
Before administration, 5minutes, 24 hours, 48 hours after administration
Title
Image quality score before administration
Description
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.
Time Frame
Before administration
Title
Image quality score at 5 minutes
Description
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.
Time Frame
5 minutes after administration
Title
Image quality score at 24 hours
Description
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.
Time Frame
24 hours after administration
Title
Image quality score at 48 hours
Description
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.
Time Frame
48 hours after administration
Secondary Outcome Measure Information:
Title
T2* value of Liver
Description
T2* signals in the liver were quantitatively detected by magnetic resonance scanning
Time Frame
Before administration, and day 28, day 60, day 90 after administration
Title
R2 value of Liver
Description
R2 signals in the liver were quantitatively detected by magnetic resonance scanning
Time Frame
Before administration, and day 28, day 60, day 90 after administration
Title
Magnetic sensitivity of brain tissue
Description
Magnetic resonance scanning was used to quantitatively detect magnetic sensitivity of brain tissue
Time Frame
Before administration, and day 28, day 60, day 90 after administration
Title
Incidence of adverse events
Description
The incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Time Frame
From the enrollment of the subjects to 90 days after administration
Title
Incidence of severe adverse events
Description
The incidence of severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Time Frame
From the enrollment of the subjects to 90 days after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.; Age: ≥18 years old (at the time of signing the informed consent), gender is not limited; Patients diagnosed with Chronic Kidney Disease (CKD, 2012 KDIGO Guidelines); Eastern Cooperative Oncology Group (ECOG) score 0~1; Expected survival ≥3 months; Serum ferritin ≤ 1000μg/L and transferrin saturation ≤ 50%; The major organs function are good and meet the following criteria: blood routine examination: Hemoglobin ≥ 90g/L Neutrophil count (NEUT) ≥1.5×109/L; Platelet count (PLT) ≥ 75×109/L; Biochemical examination should meet the following standards: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine transferase (ALT), aspartate transferase (AST) and gamma glutamyltransferase (gamma-GGT) ≤ 3ULN; Left ventricular ejection fraction (LVEF) ≥50%. Women of reproductive age should agree to use effective birth control during the study period and for 6 months after the study, and have a negative serum-pregnancy test within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period. Exclusion Criteria: Had or currently have malignant tumors within 3 years. The following three conditions were eligible for inclusion: patients with other malignancies treated with a single operation achieved continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; The disease was stable as assessed by the investigators, and the concomitant drugs did not affect medication during the trial and follow-up period. Subjects with any severe and/or uncontrolled medical conditions, including: Poorly controlled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg) or poorly controlled hypotension (systolic blood pressure <90mmHg or diastolic blood pressure <60 mmHg); Have ≥ grade 2 myocardial ischemia or myocardial infarction and/or severe or malignant arrhythmias [including QTc ≥450ms in men, QTc ≥470ms in women] and/or ≥ grade 2 congestive heart failure [New York Heart Association (NYHA)]; Active infection (≥NCI, CTC AE 5.0, Grade 2); Viral hepatitis, syphilis, HIV and other infectious diseases; A history of immunodeficiency, including acquired or congenital immunodeficiency diseases, or a history of organ transplantation; People who have epilepsy and require treatment. Research and treatment related: Patients with iron deficiency anemia; Subjects who are allergic to intravenous iron preparations, the investigational drug or any of its components, or two or more types of drugs; Subjects who plan to undergo magnetic resonance imaging during the study period and during follow-up. Participants who have participated in other clinical trials of drugs or medical device within 28 days before the start of the study treatment; Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders; Pregnant or lactating women; Patients with non-magnetic compatible metal foreign bodies (false teeth, contraceptive rings, metal implants, metal clips, etc.) and claustrophobia; Patients with difficulty or inability to tolerate MRI scanning; Subjects with concomitant diseases that, in the investigator's judgment, seriously endanger subjects' safety or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Yang, Doctor
Phone
+86 028-85423837

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging

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