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MRL in the Upper Extremity

Primary Purpose

Lymphedema of Upper Limb

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Magnetic Resonance Lymphography

About this trial

This is an interventional diagnostic trial for Lymphedema of Upper Limb

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Scannexus

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Lymphedema patients

Healthy volunteers

Arm Description

MRL examination in lymphedema patients

MRL examination in healthy volunteers

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04575636

First Posted

July 15, 2020

Last Updated

October 19, 2023

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04575636

Brief Title

MRL in the Upper Extremity

Official Title

Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema of Upper Limb

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lymphedema patients

Arm Type

Other

Arm Description

MRL examination in lymphedema patients

Arm Title

Healthy volunteers

Arm Type

Other

Arm Description

MRL examination in healthy volunteers

Intervention Type

Diagnostic Test

Intervention Name(s)

Magnetic Resonance Lymphography

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

0.5 hours per participant

Secondary Outcome Measure Information:

Title

lymphedema staging by evaluating the MRL output images

Description

Time Frame

0.5 hours per participant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Scannexus

City

Maastricht

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

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MRL in the Upper Extremity

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