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Completed

NCT Number: NCT04575636

MRL in the Upper Extremity

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.

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Key information

Conditions

Lymphedema of Upper Limb

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scannexus

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Lymphography

Diagnostic Test

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

Primary outcomes

  1. feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images

    Time frame: 0.5 hours per participant

    Describing lymphatic vessel characteristics in terms of size, diameter and course, and lymphedema symptoms such as dermal backflow or obstruction

Secondary outcomes

  1. lymphedema staging by evaluating the MRL output images

    Time frame: 0.5 hours per participant

    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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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