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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Procedure: non-contrast enhanced abdomen and pelvis MRI
    non-contrast enhanced abdomen and pelvis MRI
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
  • Procedure: non-contrast enhanced abdomen and pelvis MRI
    non-contrast enhanced abdomen and pelvis MRI
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
  • Procedure: non-contrast enhanced abdomen and pelvis MRI
    non-contrast enhanced abdomen and pelvis MRI

Recruiting Locations

University of Massachusetts
Worcester, Massachusetts 01655
Contact:
Noelle Bodkin
774-441-8442
noelle.bodkin@umassmed.edu

More Details

Status
Recruiting
Sponsor
Ningcheng Peter Li

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.