Lymphedema of Upper LimbNCT04575636
MRL in the Upper Extremity
A study testing Magnetic Resonance Lymphography in people with Lymphedema of Upper Limb, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- Magnetic Resonance Lymphography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Sep 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- informed consent
- BMI < 30 kg/m2
- Group A:
- Secondary lymphedema in the upper extremity
- Group B:
- Healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects
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+.
Read more
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
- Being tested
- Magnetic Resonance Lymphography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance LymphographyDiagnostic test
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
| Study group | Role | What they receive |
|---|---|---|
| Lymphedema patients | Other | MRL examination in lymphedema patients Receives: Diagnostic Test: Magnetic Resonance Lymphography |
| Healthy volunteers | Other | MRL examination in healthy volunteers Receives: Diagnostic Test: Magnetic Resonance Lymphography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0.5 hours per participant
Secondary outcomes (1)
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.
Measured: 0.5 hours per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575636
- Sponsor's protocol ID
- NL72424.068.19
- Status last verified
- Oct 2023
- First submitted
- 15 Jul 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects
- ClinicalTrials.gov ID
- NCT04575636
- Acronym / sponsor ID
- NL72424.068.19
- Conditions
- Lymphedema of Upper Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphedema patients | Other | Diagnostic Test: Magnetic Resonance LymphographyMRL examination in lymphedema patients |
| Healthy volunteers | Other | Diagnostic Test: Magnetic Resonance LymphographyMRL examination in healthy volunteers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- informed consent
- BMI < 30 kg/m2
- Secondary lymphedema in the upper extremity
- Healthy volunteers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance LymphographyMagnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system | Diagnostic test | Healthy volunteers, Lymphedema patients |
Primary outcome
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
1 secondary outcome
lymphedema staging by evaluating the MRL output images
Time frame: 0.5 hours per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Lymphography in people with Lymphedema of Upper Limb, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images (time frame: 0.5 hours per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.