MRI for May-Thurner Syndrome

Overseen By Noelle Bodkin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ningcheng Peter Li

Disqualifiers: Pelvic disease, MRI contraindication, prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores blood flow through the pelvic veins using MRI scans. It aims to understand patterns in healthy individuals, those with May-Thurner syndrome (a condition where the left iliac vein is compressed), and people with a stent in the iliac vein. The research seeks to identify normal and abnormal blood flow characteristics to improve treatments. Potential participants include those with symptoms of May-Thurner syndrome or a history of having a stent placed in the iliac vein. Healthy volunteers without any history of pelvic vein issues are also needed. As an unphased trial, this study allows participants to contribute to foundational research that could lead to better diagnostic and treatment options for pelvic vein conditions.

What prior data suggests that this MRI technique is safe for assessing iliac vein flow?

Research shows that the type of MRI used in this study, known as 2D and 4D flow MRI, is generally easy for participants to handle. This imaging method is safe and does not use contrast agents, reducing the risk of allergic reactions. For individuals with May-Thurner syndrome, this MRI provides a clear view of blood flow without any known side effects.

For those with an iliac stent, similar MRI methods have been used successfully. Studies indicate that these scans do not harm the stent or affect blood flow. Reports of negative side effects from these MRI scans are uncommon.

Overall, evidence suggests that 2D and 4D flow MRI safely examines blood flow in the pelvis, offering reassurance about the procedure's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of 2D and 4D flow MRI without contrast to better understand May-Thurner Syndrome and related conditions. Unlike traditional imaging methods that often require contrast agents, which can pose risks for some patients, this technique provides a non-invasive way to evaluate blood flow dynamics. This approach could lead to safer, more comfortable diagnostics for patients with or without prior treatments like stent placements. By providing detailed insights into blood flow, it could transform how we diagnose and monitor pelvic venous diseases, potentially improving patient outcomes with less risk.

What evidence suggests that this MRI technique is effective for assessing May-Thurner syndrome?

Research has shown that 2D and 4D flow MRI can help examine blood flow in the pelvic veins, which is important for conditions like May-Thurner syndrome. In this trial, participants with left iliac vein compression syndrome will undergo these imaging methods to clearly show how blood moves through the veins, aiding in the understanding and diagnosis of vein compression. Another group of participants, those with stents in their iliac veins, will also undergo 4D flow MRI to assess stent performance by showing blood flow unaffected by metal. Additionally, healthy volunteers with no imaging evidence of iliac venous disease will be studied to provide baseline comparisons. These techniques have the potential to improve the diagnosis and management of long-term vein problems. Overall, 2D and 4D flow MRI offer valuable insights that could lead to better treatment outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Ningcheng Li, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for individuals with or without May-Thurner Syndrome, which is a condition where the left iliac vein is compressed. It's also for those who have had stents placed in their iliac veins. Participants should be suitable candidates for MRI scans.

Inclusion Criteria

Arm 3: History of left iliac vein stent placement

I have no history of vein problems in my pelvis.

I have symptoms or scans showing pressure on my left pelvic vein.

Exclusion Criteria

I am unable to give informed consent.

Arm 1: Contraindication to MRI examination

I have had issues or treatments related to veins in my pelvis or hip area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline flow characteristics of the iliac veins are established using 2D and 4D flow MRI

At Enrollment

1 visit (in-person)

Follow-up

Participants are monitored for changes in flow characteristics and quality-of-life measures

36 months

Multiple visits at 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Trial Overview The study tests how blood flows through pelvic veins using two types of MRI: 2D and 4D flow MRI. The goal is to understand normal and abnormal flow patterns to help future research on blood flow dynamics.

How Is the Trial Designed?

Group I: Patients with no imaging evidence of iliac venous disease Experimental Treatment 1 Intervention

Healthy volunteers with no self-reported history or prior imaging evidence of pelvic venous disease or associated symptoms to undergo 2D and 4D flow MRI without contrast administration

Group II: Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). Experimental Treatment 1 Intervention

Patients with prior imaging evidence of left common iliac vein compression syndrome to undergo 2D and 4D flow MRI without contrast administration

Group III: Patients status post iliac stent placement Experimental Treatment 1 Intervention

Patients with a history of iliac stent placement to undergo 2D and 4D flow MRI without contrast administration

Who Is Running the Clinical Trial?

Ningcheng Peter Li

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06888024?cond=%22May-Thurner%20Syndrome%22&viewType=Table&rank=8

Pelvic Vein Quantitative Flow Characterization Using 2D ... Experimental : Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). Patients with prior imaging evidence of left common iliac vein ...

2. trialx.com trialx.com/clinical-trials/listings/324515/pelvic-vein-quantitative-flow-characterization-using-2d-and-4d-flow-mri/

Pelvic Vein Quantitative Flow Characterization Using 2D ... The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40209877/

Evaluation of hemodynamic characteristics of iliac vein in ... After computational tomography venography (CTV) scans to verify iliac vein compression, every patient underwent 2D-PC and 4D-Flow MRI scanning.

4. jvsvenous.org jvsvenous.org/article/S2213-333X(25)00082-4/fulltext

Evaluation of hemodynamic characteristics of iliac vein in ... 2D-PC and 4D-Flow MRI possess the potential clinical value of assisting chronic venous disease and iliac vein compression diagnosis and lower ...

5. ctv.veeva.com ctv.veeva.com/study/pelvic-vein-quantitative-flow-characterization-using-2d-and-4d-flow-mri

Pelvic Vein Quantitative Flow Characterization Using 2D and ... The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8569277/

May-Thurner syndrome - PMC May-Thurner syndrome (MTS) is a venous compression syndrome in which the left common iliac vein (LCIV) is compressed between the lower lumbar spine and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5220205/

Imaging of venous compression syndromes - PubMed Central While uncommon, they may cause serious complications including pain, swelling, deep venous thrombosis (DVT), pulmonary embolism, and post-thrombotic syndrome.

8. mdpi.com mdpi.com/2306-5354/10/6/688

CFD Study of the Effect of the Angle Pattern on Iliac Vein ... In this study, we investigated how the tilt angle of the left common iliac vein affects the flow patterns in the compressed blood vessel.