Evaluation of the help which may be brought by visualisation of the lymphatic network by injection of a fluorescent molecule in the treatment of lymphedema by manual drainage.

Evaluation of the benefit of lymphofluoroscopy in the validation of the manual drainage techniques on lymphedema

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001360-36-BE

Enrollment

Registered

2013-08-08

Start date

2013-09-30

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

upper limb lymphedema

Interventions

Trade Name: Indocyanine Green PULSION 25 mg Product Name: Indocyanine Green 25mg Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: INDOCYANINE GREEN CAS Number: 3599-32-4 Cur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with (primary or secundary) upper limb lymphedema. - Healthy volunteers - Informed consent signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known allergy to iodine or shellfish. - Incapability to give informed consent. - < 18 years. - Pregnant or lactating women. - Coronary disease. - Important renal impairement. - Hyperthyroidism.

Design outcomes

Primary

Measure	Time frame
Main Objective: - visualization with our fluorescence camera of the superficial lymphatic network of patients with (primary or secondary) upper limb lymphedema. - quantification of lymph displacement into these superficial lymphatic vessels (contraction rate of the lymphagion, lymph output…) in different situations (at rest, during exercises, during MLD session…). - comparison of the effect of different MLD techniques on the measurements performed. - improvement of the drainage maneuvers applied according to the results obtained with lymphofluoroscopy. ;Secondary Objective: - comparison of the results obtained between patients and healthy people. - fluorescence-based observation of the architecture of the superficial lymphatic network in theses patients. ;Primary end point(s): - visualization with our fluorescence camera of the superficial lymphatic network of patients with (primary or secondary) upper limb lymphedema. - quantification of lymph displacement into these superficial lymphatic vessels (contraction rate of the lymphagion, lymph output…) in different situations (at rest, during exercises, during MLD session…). - comparison of the effect of different MLD techniques on the measurements performed. - improvement of the drainage maneuvers applied according to the results obtained with lymphofluoroscopy. ;Timepoint(s) of evaluation of this end point: after analysis of the acquired images	—

Measure

Time frame

Main Objective: - visualization with our fluorescence camera of the superficial lymphatic network of patients with (primary or secondary) upper limb lymphedema. - quantification of lymph displacement into these superficial lymphatic vessels (contraction rate of the lymphagion, lymph output…) in different situations (at rest, during exercises, during MLD session…). - comparison of the effect of different MLD techniques on the measurements performed. - improvement of the drainage maneuvers applied according to the results obtained with lymphofluoroscopy. ;Secondary Objective: - comparison of the results obtained between patients and healthy people. - fluorescence-based observation of the architecture of the superficial lymphatic network in theses patients. ;Primary end point(s): - visualization with our fluorescence camera of the superficial lymphatic network of patients with (primary or secondary) upper limb lymphedema. - quantification of lymph displacement into these superficial lymphatic vessels (contraction rate of the lymphagion, lymph output…) in different situations (at rest, during exercises, during MLD session…). - comparison of the effect of different MLD techniques on the measurements performed. - improvement of the drainage maneuvers applied according to the results obtained with lymphofluoroscopy. ;Timepoint(s) of evaluation of this end point: after analysis of the acquired images

—

Secondary

Measure	Time frame
Secondary end point(s): - comparison of the results obtained between patients and healthy people. - fluorescence-based observation of the architecture of the superficial lymphatic network in theses patients. ;Timepoint(s) of evaluation of this end point: after analysis of the acquired images	—

Countries

Belgium

Contacts

Public ContactPhD student

Université Libre de Bruxelles

belgrado@ulb.ac.be0032475633434

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026