Venous Diseases
Conditions
Brief summary
The purpose of this single-center, prospective, evaluator-blinded study is to establish and optimize the imaging protocol for ferumoxytol-enhanced magnetic resonance venography (Fe-MRV) in patients with venous system diseases. Current gadolinium-based contrast agents used in MRI have limitations, including short circulation half-lives and potential risks for patients with renal impairment. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, offers a longer imaging window and no renal toxicity, making it a promising alternative for vascular imaging. This study will enroll 50 adult patients with suspected or confirmed venous structural abnormalities or circulation disorders. To determine the minimum effective diagnostic dose, each participant will receive a total dose of 3.0 mg/kg, administered as four equal intravenous aliquots, with MRI performed after each aliquot (cumulative doses: 0.75, 1.50, 2.25, and 3.0 mg/kg). Independent, blinded radiologists will evaluate the image quality at each cumulative dose level to determine the lowest possible dose required to achieve successful clinical diagnosis.
Interventions
Ferumoxytol is a superparamagnetic iron oxide nanoparticle contrast agent. It is administered intravenously at a total dose of 3.0 mg/kg, divided into four equal consecutive aliquots (0.75 mg/kg each).
Sponsors
Min Zhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years. * Suspected or preliminarily diagnosed venous structural abnormalities (e.g., lower-extremity veins, central veins) or venous circulation disorders requiring Fe-MRV evaluation. * Able and willing to provide written informed consent.
Exclusion criteria
* History of allergy/hypersensitivity to iron or dextran, or known allergy-prone constitution. * Currently receiving other oral or intravenous iron products. * Hemosiderosis or hemochromatosis. * Prior hypersensitivity reaction to intravenous iron products, or any condition associated with iron overload. * Unable to undergo MRI for psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-MRI-compatible metallic implants/foreign bodies). * End-stage disease or life expectancy \< 1 year. * Pregnant women. * Any other condition judged by the investigator to make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Diagnostic Success Rate | Up to 2 days post-intervention | The overall diagnostic success rate is defined as the proportion of vascular segments with an average image quality score of ≥ 3 (evaluated on a 5-point Likert scale, where 1 = non-diagnostic/unusable and 5 = excellent). A segment is considered successfully diagnosed only if two independent, blinded radiologists reach a consensus that it is "diagnosable". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Signal-to-Noise Ratio (SNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography | Up to 2 days post-intervention | Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical region of interest (ROI) covering approximately two-thirds of the vascular lumen will be employed to minimize the effect of partial volume effects. SNR is calculated as the mean signal intensity of the vessel divided by the standard deviation (SD) of the vessel signal intensity. The vessel SD is used in place of background SD, as SNR calculated using background SD is inconsistent across regions of an accelerated sparse image. |
| Contrast-to-Noise Ratio (CNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography | Up to 2 days post-intervention | Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical ROI covering approximately two-thirds of the vascular lumen will be employed to minimize partial volume effects. The reference signal and standard deviation (SD) of the adjacent muscle will be measured on the same slice. CNR is calculated as the difference between the mean signal intensity of the vessel and that of the adjacent muscle, divided by the square root of the sum of the squared SDs of the vessel and the adjacent muscle. |
Countries
China
Contacts
CONTACTGuangxiang Si
Outcome results
None listed