MRL in the Upper Extremity

NCT04575636 | Completed DMC

• 1 other identifier: NL72424.068.19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• lymphedema staging by evaluating the MRL output images

  0.5 hours per participant

Study Arms (2)

Lymphedema patients

OTHER

MRL examination in lymphedema patients

Diagnostic Test: Magnetic Resonance Lymphography

Healthy volunteers

OTHER

MRL examination in healthy volunteers

Diagnostic Test: Magnetic Resonance Lymphography

Interventions

Magnetic Resonance Lymphography DIAGNOSTIC_TEST

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

Healthy volunteers; Lymphedema patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• informed consent
• BMI \< 30 kg/m2
• Group A:
• \- Secondary lymphedema in the upper extremity
• Group B:
• \- Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Scannexus

Maastricht, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: October 5, 2020
• Study Start: September 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)