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MRL in the Upper Extremity

NCT04575636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • Lymphedema of Upper Limb

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Lymphography

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2022-12-31
Completion
2023-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575636 on ClinicalTrials.gov