Magnetic Resonance ImagingPhase 1NCT05687864
Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
A Phase 1 study testing Polysaccharide superparamagnetic ferric oxide injection in people with Magnetic Resonance Imaging and Chronic Kidney Diseases, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Magnetic Resonance Imaging, Chronic Kidney Diseases
- What is being tested?
- Polysaccharide superparamagnetic ferric oxide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2023to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Qi Yang, Doctor, +86 028-85423837
About this study
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
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.
- Being tested
- Polysaccharide superparamagnetic ferric oxide injection
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysaccharide superparamagnetic ferric oxide injectionDiagnostic test
The polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent
| Study group | Role | What they receive |
|---|---|---|
| Polysaccharide superparamagnetic ferric oxide injection | Experimental | 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. Receives: Diagnostic Test: Polysaccharide superparamagnetic ferric oxide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours after administration
Secondary outcomes (5)
T2* value of Liver
T2* signals in the liver were quantitatively detected by magnetic resonance scanning
Measured: Before administration, and day 28, day 60, day 90 after administration
R2 value of Liver
R2 signals in the liver were quantitatively detected by magnetic resonance scanning
Measured: Before administration, and day 28, day 60, day 90 after administration
Magnetic sensitivity of brain tissue
Magnetic resonance scanning was used to quantitatively detect magnetic sensitivity of brain tissue
Measured: Before administration, and day 28, day 60, day 90 after administration
Incidence of adverse events
The incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured: From the enrollment of the subjects to 90 days after administration
Incidence of severe adverse events
The incidence of severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured: From the enrollment of the subjects to 90 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start17 Jun 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687864
- Sponsor's protocol ID
- DJTCSCYHT-I-04
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05687864
- Acronym / sponsor ID
- DJTCSCYHT-I-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysaccharide superparamagnetic ferric oxide injection | Experimental | Diagnostic Test: Polysaccharide superparamagnetic ferric oxide injectionParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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%;
Key exclusion criteria (20 listed)
- Had or currently have malignant tumors within 3 years. The following three conditions were eligible for inclusion:
- Subjects with any severe and/or uncontrolled medical conditions, including:
- Research and treatment related:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysaccharide superparamagnetic ferric oxide injectionThe polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent | Diagnostic test | Polysaccharide superparamagnetic ferric oxide injection |
Primary outcome
Signal-to-Noise Ratio (SNR)
Time frame: Before administration, 5minutes, 24 hours, 48 hours after administration
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)
Time frame: Before administration, 5minutes, 24 hours, 48 hours after administration
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
Time frame: 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
Time frame: 5 minutes after 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 24 hours
Time frame: 24 hours after 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 48 hours
Time frame: 48 hours after 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.
5 secondary outcomes
T2* value of Liver
Time frame: Before administration, and day 28, day 60, day 90 after administration
R2 value of Liver
Time frame: Before administration, and day 28, day 60, day 90 after administration
Magnetic sensitivity of brain tissue
Time frame: Before administration, and day 28, day 60, day 90 after administration
Incidence of adverse events
Time frame: From the enrollment of the subjects to 90 days after administration
Incidence of severe adverse events
Time frame: From the enrollment of the subjects to 90 days after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polysaccharide superparamagnetic ferric oxide injection in people with Magnetic Resonance Imaging and Chronic Kidney Diseases, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-Noise Ratio (SNR) (time frame: Before administration, 5minutes, 24 hours, 48 hours after administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.