MRL in the Upper Extremity

Lymphedema of Upper Limb Clinical Trial

Official title:

Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575636
• Other study ID #: NL72424.068.19
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: The aim of this study is to examine the feasibility and applicability of the MRL protocol for the upper extremity in Maastricht University Medical Center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers.

Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht University Medical Center+.

Study population: There are two study groups. The first group (n=10) consists of patients with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy volunteers.

Intervention (if applicable):

All participants will undergo an MRL examination with the same protocol, developed in a previous 'proof of principle' study, in the Maastricht University Medical Center+.

After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be made before the injection of contrast. After the injection of the contrast agent a T1-weighted sequences of the upper and lower arm are performed alternately.

Main study parameters/endpoints:

The primary outcome is to determine the feasibility and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects.

The secondary outcome is to assess the value of MRL in staging lymphedema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 years or older

• informed consent

• BMI < 30 kg/m2

Group A:

• Secondary lymphedema in the upper extremity

Group B:

• Healthy volunteers

Exclusion Criteria:

• Active skin infection/erysipelas in the arm.

• Known allergy for a contrast agent

• History of surgical intervention in the arm.

• Contraindications for MRI with contrast; pregnancy, metals, prostheses, renal insufficiency, claustrophobia

• Active cancer

• Distant metastases

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Limb

Intervention

Diagnostic Test:
• Magnetic Resonance Lymphography
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system

Locations

Country	Name	City	State
Netherlands	Scannexus	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images	Describing lymphatic vessel characteristics in terms of size, diameter and course, and lymphedema symptoms such as dermal backflow or obstruction	0.5 hours per participant
Secondary	lymphedema staging by evaluating the MRL output images	Describing lymphedema stage, based on lymphatic vessel charasteristics and lymphedema symptoms as found at primary outcome. This is compared with ISL (clinical) lymphedema stage and ICG lymphography stage.	0.5 hours per participant