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

Ningcheng Peter Li

Status: Enrolling

Conditions: May-Thurner Syndrome; Iliac Venous Compression

Treatments: Procedure: non-contrast enhanced abdomen and pelvis MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06888024

STUDY00002051

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Patients with no imaging evidence of iliac venous disease

Experimental group

Description:

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

Treatment:

Procedure: non-contrast enhanced abdomen and pelvis MRI

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

Experimental group

Description:

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

Treatment:

Procedure: non-contrast enhanced abdomen and pelvis MRI

Patients status post iliac stent placement

Experimental group

Description:

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

Treatment:

Procedure: non-contrast enhanced abdomen and pelvis MRI