Clinical trial NCT06051565: Cardiovascular Contrast-enhanced Magnetic Resonance Imaging Using Polysaccharide Superparamagnetic Iron Oxide Injection in Diabetic Patients
Official title: Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Contrast-enhanced Cardiovascular Magnetic Resonance Imaging in Patients With Type 2 Diabetes and Chronic Kidney Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes
Magnetic Resonance Imaging
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label, single-center, single-dose study aims to evaluate the effect and safety of polymeric superparamagnetic iron oxide in cardiovascular magnetic resonance imaging for diabetic patients with concomitant chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years, ≤ 80 years.
* Patients who have been diagnosed with chronic kidney disease (CKD) according to diagnostic criteria, meeting at least one CKD diagnostic criterion.
* Patients with a confirmed history of atherosclerosis and/or chronic venous disease (including deep vein thrombosis, thrombotic venous inflammation, lower limb varicose veins, etc.) either in their medical history or diagnosed during hospital admission, and within the past year, at least one imaging examination has confirmed the presence of at least one of the following vascular abnormalities in at least one vascular bed:

  1. ≥50% vascular stenosis;
  2. Arterial aneurysm;
  3. Arterial dissection;
  4. Arteriovenous malformation;
  5. Arteriovenous fistula;
  6. Vascular developmental abnormalities;
  7. Varicose veins, etc. For details, please refer to the inclusion criteria section.
* Patients capable of self-care in daily life.
* Patients who voluntarily agree to participate in this study, sign an informed consent form, have a full understanding of the trial's content, procedures, and potential adverse reactions, and demonstrate good compliance.
* Patients who are unwilling to sign an informed consent form for the exploratory research can still be enrolled in the main study.
* Subjects who have no plans for pregnancy for at least 2 weeks before self-administration of the investigational drug and for at least 6 months after the last use of the investigational drug and voluntarily agree to adopt effective contraceptive measures.

Exclusion Criteria:

* Patients who have undergone stent implantation for vascular treatment in the target vascular bed.
* Patients who have had or currently have malignant tumors within the last 3 years.
* Serum ferritin \> 1000 μg/L.
* Patients who are planned to undergo magnetic resonance imaging (MRI) examination for various reasons during the trial.
* Blood donation or significant blood loss (\> 450 ml) within the two months before medication.
* Patients with a history of substance abuse involving psychotropic drugs and are unable to quit or have psychiatric disorders.
* Patients with any severe and/or uncontrolled diseases, including:

  1. Outpatients diagnosed through medical history; inpatients diagnosed based on past medical history and current medical history indicating ≥ Grade 2 myocardial ischemia or myocardial infarction, ≥ Grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
  2. Active or uncontrolled severe systemic infections (≥ Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Grade 2).
* Infectious diseases such as cirrhosis, active hepatitis\*, syphilis, human immunodeficiency virus (HIV), etc. \*Reference for hepatitis B: hepatitis B surface antigen (HBsAg) positive and Hepatitis B Virus (HBV) DNA test value exceeds the upper limit of normal; Reference for hepatitis C: Hepatitis C Virus (HCV) antibody positive and HCV viral titer test value exceeds the upper limit of normal.
* History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation.
* Pregnancy or currently breastfeeding or planning to breastfeed during the study.
* Presence of metal objects in the body (dentures, contraceptive rings, metal implants, metal clips, etc.) and claustrophobia.
* Allergic reactions to the investigational drug, its metabolites, or excipients.
* Use of the investigational drug or participation in drug clinical trials within the two months before medication.
* Difficulty with or intolerance to MRI scans.
* Subjects who cannot or will not comply with the hospital management regulations.
* According to the investigator's judgment, patients with accompanying diseases that pose a serious risk to patient safety or may interfere with the completion of the study, or patients deemed unsuitable for inclusion for other reasons.

Primary outcomes:
measure: The number of vascular segments with lesions
timeFrame: 0 hour after administration
measure: Lesion length
timeFrame: 0 hour after administration
measure: Degree of vascular stenosis
timeFrame: 0 hour after administration
Secondary outcomes:
measure: Image quality scores
timeFrame: 0 hour after administration
measure: Myocardium T1 values
timeFrame: 0 hour after administration
measure: Signal-to-noise ratio
timeFrame: 0 hour after administration
measure: Contrast-to-noise ratio
timeFrame: 0 hour after administration
measure: Adverse event rate
timeFrame: Baseline up to 24 hours after administration
measure: Serum iron
timeFrame: Baseline up to 24 hours after administration
measure: Serum ferritin
timeFrame: Baseline up to 30 days and 60 days after administration
measure: Total iron-binding capacity
timeFrame: Baseline up to 30 days and 60 days after administration
measure: Serum transferrin saturation
timeFrame: Baseline up to 30 days and 60 days after administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
Study officials:
References: