MRI for May-Thurner Syndrome

Overseen By Sara Schiller, MPH, CCRP

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?

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 establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis. Arm 1: To establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease. Arm 2: To assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). Arm 3: To assess the flow characteristics of the iliac veins in patients status post iliac stent placement.

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+