Healthy volunteers MedDRA version: 19.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: ICG-PULSION(R)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3
Sponsors
Bispebjerg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy. 2. Capable. 3. Age 18-65 years. 4. Normal BMI range (18-25 kg/m2 ). 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any known disease. 2. Any chronic medication. 3. Pregnancy or lactation. A negative urine-HCG pregnancy test on the day of participation is mandatory for fertile women subjects. 4. Contraindications to the use of ICG-PULSION® as specified in the Summary of Product Characteristics provided by the manufacturer (Pulsion Medical Systems AG) 5. Smoking or other nicotine chronic use. 6. Clinical signs of oedema (pitting, swelling), venous insufficiency (pigmentation, dermatosclerosis, wounds) or local inflammation (erythema, swelling, warm skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess normal anatomy and dynamics of pumping activity in extremity lymphatic collectors with near infrared fluorescence imaging ; Secondary Objective: To measure the effect of specific factors in method and physical perturbations on extremity lymphatic pumping activity Method factors: (1) Time from depot injection to imaging, (2) ICG concentration, (3) Injected volume, (4) Level of injection - s.c. vs. i.d. Physical perturbations: (1) Skin heating, (2) Depot dependency, (3) Exercise, (4) Solution tonicity. ;Primary end point(s): Anatomy and pumping activity of extremity lymphatic collectors.; Timepoint(s) of evaluation of this end point: When 10 subjects in each group with complete data sets have participated according to protocol and the technical result (video quality) is acceptable (analysable). If a data set from a subject is rejected due to poor technical result, a matched substitute subject is recruited. The maximum total number of subjects in the trial is 40. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Denmark
Contacts
Public ContactDept Clin Physiol Nucl Med & PET
Rigshospitalet
Outcome results
None listed