RecruitingNot Applicable

Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI

United States15 participantsStarted 2025-04-01

Plain-language summary

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 can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Arm 1: Inclusion Criteria: • No self-reported history of pelvic or iliac venous disease or associated symptoms Exclusion Criteria: * History of pelvic or iliac venous disease or intervention * Contraindication to MRI examination * Prisoners * Subjects ≤ 18 years of age * Pregnant women * Adults unable to provide informed consent Arm 2: Inclusion Criteria: • Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome Exclusion Criteria: * History of pelvic or iliac venous intervention * Contraindication to MRI examination * Prisoners * Subjects ≤ 18 years of age * Pregnant women * Adults unable to provide informed consent Arm 3: Inclusion Criteria: • History of left iliac vein stent placement Exclusion Criteria: * Contraindication to MRI examination * Prisoners * Subjects ≤ 18 years of age * Pregnant women * Adults unable to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Flow Volume

Timeframe: At Enrollment

12-month primary patency rate

Timeframe: 12 Months

Trial details

NCT IDNCT06888024

SponsorNingcheng Peter Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Noelle Bodkin

774-441-8442. noelle.bodkin@umassmed.edu

View on ClinicalTrials.gov More May-Thurner Syndrome trials