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

NCT06888024 | Recruiting

• 1 other identifier: STUDY00002051
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

May-Thurner Syndrome; Iliac Venous Compression

Keywords

May-Thurner Syndrome; Iliac Venous Disease

Outcome Measures

Primary Outcomes (2)

• Flow Volume

  Flow volume in the iliac veins calculated based on the 2D and 4D flow MRI obtained.

  At Enrollment

• 12-month primary patency rate

  Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization

  12 Months

Secondary Outcomes (10)

• Flow Velocity Profile

  At Enrollment

• Quality-of-life measure: Venous clinical severity score (VCSS)

  Baseline to 6 Months, 12 Months, 24 Months, 36 Months

• Quality-of-life measures

  Baseline to 6 Months, 12 Months, 24 Months, 36 Months

• Technical success

  Index Procedure

• Target vessel revascularization

  30 days, 6 months, 12 months, 24 months, 36 months

Study Arms (3)

Patients with no imaging evidence of iliac venous disease

EXPERIMENTAL

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

Procedure: non-contrast enhanced abdomen and pelvis MRI

Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).

EXPERIMENTAL

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

Procedure: non-contrast enhanced abdomen and pelvis MRI

Patients status post iliac stent placement

EXPERIMENTAL

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

Procedure: non-contrast enhanced abdomen and pelvis MRI

Interventions

non-contrast enhanced abdomen and pelvis MRI PROCEDURE

non-contrast enhanced abdomen and pelvis MRI

Patients status post iliac stent placement; Patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome).; Patients with no imaging evidence of iliac venous disease

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No self-reported history of pelvic or iliac venous disease or associated symptoms

You may not qualify if:

• 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
• Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome
• 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
• History of left iliac vein stent placement
• Contraindication to MRI examination

Sponsors & Collaborators

• Ningcheng Peter Li: lead

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ningcheng Li, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noelle Bodkin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 21, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)