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

NCT ID: NCT06888024

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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May-Thurner Syndrome Iliac Venous Compression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

non-contrast enhanced abdomen and pelvis MRI

Intervention Type PROCEDURE

non-contrast enhanced abdomen and pelvis MRI

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

Group Type EXPERIMENTAL

non-contrast enhanced abdomen and pelvis MRI

Intervention Type PROCEDURE

non-contrast enhanced abdomen and pelvis MRI

Patients status post iliac stent placement

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

Group Type EXPERIMENTAL

non-contrast enhanced abdomen and pelvis MRI

Intervention Type PROCEDURE

non-contrast enhanced abdomen and pelvis MRI

Interventions

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non-contrast enhanced abdomen and pelvis MRI

non-contrast enhanced abdomen and pelvis MRI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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


• Clinical symptoms or imaging findings compatible with left iliac vein compression syndrome


• History of left iliac vein stent placement

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


* 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


* Contraindication to MRI examination
* Prisoners
* Subjects ≤ 18 years of age
* Pregnant women
* Adults unable to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ningcheng Peter Li

OTHER

Sponsor Role lead

Responsible Party

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Ningcheng Peter Li

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ningcheng Li, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

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University of Massachusetts

Worcester, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Noelle Bodkin

Role: CONTACT

774-441-8442.

Facility Contacts

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Noelle Bodkin

Role: primary

774-441-8442

Other Identifiers

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STUDY00002051

Identifier Type: -

Identifier Source: org_study_id

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