Validation of a Magnetic Resonance Lymphography protocol in upper extremity lymphedema and healthy subjects*

Validation of a Magnetic Resonance Lymphography protocol in upper extremity lymphedema and healthy subjects* - MRL in the upper extremity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49628

Enrollment

Registered

2020-03-25

Start date

2020-09-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

edema of the arm lymphedema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or older - informed consent - BMI

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary outcome is to determine the feasiblity and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects. MRL images and 3D MIPs will be evaluated by an experienced radiologist and plastic surgeon and scored on the following points: qualitative and quantitative visibility of veins and lymph vessels, location, depth, (abnormal) pattern, diameter, and overall image quality on a scale of 10. Moreover, differences in the lymphatic system between the lymphedema patients and healthy volunteers will be assessed.	—

Measure

Time frame

The primary outcome is to determine the feasiblity and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects. MRL images and 3D MIPs will be evaluated by an experienced radiologist and plastic surgeon and scored on the following points: qualitative and quantitative visibility of veins and lymph vessels, location, depth, (abnormal) pattern, diameter, and overall image quality on a scale of 10. Moreover, differences in the lymphatic system between the lymphedema patients and healthy volunteers will be assessed.

—

Secondary

Measure	Time frame
The images and 3D MIPs will be compared with clinical staging according to the International Society of Lymphology (ISL) classification and Indocyanine green (ICG) lymphography. Clinical classification and ICG Lymphography is performed as standard care at the outpatient-clinic to evaluate lymphedema and as workup for surgical treatment. The dermal backflow stage, as described by, is used in the staging of lymphedema.	—

Measure

Time frame

The images and 3D MIPs will be compared with clinical staging according to the International Society of Lymphology (ISL) classification and Indocyanine green (ICG) lymphography. Clinical classification and ICG Lymphography is performed as standard care at the outpatient-clinic to evaluate lymphedema and as workup for surgical treatment. The dermal backflow stage, as described by, is used in the staging of lymphedema.

—

Countries

Netherlands

Outcome results