Recruiting

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

Sponsor:

Ningcheng Peter Li

Code:

NCT06888024

Conditions

May-Thurner Syndrome

Iliac Venous Compression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

non-contrast enhanced abdomen and pelvis MRI

Study Details

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

Study ID

NCT06888024

Start date

Apr 1, 2025

Status verified date

Sep, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Patients with no imaging evidence of iliac venous disease

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

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

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

experimental: Patients status post iliac stent placement

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

Interventions

non-contrast enhanced abdomen and pelvis MRI

Primary outcome measure

Flow Volume [ Time Frame: At Enrollment ]
12-month primary patency rate [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Noelle Bodkin

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

Locations

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Noelle Bodkin

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

More Information

Sponsor

Ningcheng Peter Li

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

May-Thurner Syndrome
Iliac Venous Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ningcheng Peter Li on 2025-09-24.