Explore the clinical feasibility of LED-based PAI of the lymphatic vessels and circulatory system in patients with secondary limb lymphedema.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Lymfoedeem, Secundair
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the possibility of depiction lymphatic vessels and veins in
two-dimensional images on locations with lymphatic vessels determined with
NIRF-L and locations with dermal backflow and compare PAI and NIRF-L findings.
Secondary outcome
Secondary parameters are: the depth and diameter of the lymphatic vessels and
veins, possibility of depiction of lymphatic vessels and veins in
three-dimensional images and the possibility to detect lymphatic vessels behind
dermal backflow patterns.
Background summary
Secondary limb lymphedema is a debilitating condition often resulting from
surgical or radiotherapeutic cancer treatment. Imaging of the lymphatic vessels
is necessary for surgical planning of lympho-venous bypass (LVB) surgery to
treat secondary lymphedema in patients that are refractory to conventional
treatments. Indocyanine green (ICG) mediated near-infrared fluorescence
lymphography (NIRF-L) is currently used to visualize lymphatic vessels and
dermal backflow (i.e., lymphatic leakage into the interstitium), which
indicates failure of the lymphatic systems to transport lymph fluid. NIRF-L
suffers from several disadvantages, which limit the information that is needed
to accurately determine if a patient is a candidate for surgery and choose the
optimal site to perform an anastomosis. Photoacoustic imaging (PAI) is a
promising imaging technique that can overcome several of these disadvantages.
Study objective
Explore the clinical feasibility of LED-based PAI of the lymphatic vessels and
circulatory system in patients with secondary limb lymphedema.
Study design
This study is a prospective, researcher initiated, feasibility study.
Study burden and risks
Participation only takes ~30 minutes of a patient*s time. Imaging will take
place directly after NIRF-L, so no extra travel time is needed for the
patients. There is no ICG injected for the purpose of this study, the ICG is
injected before as a part of the regular imaging protocol. The imaging itself
is not uncomfortable and comparable to regular ultrasound imaging. Residual
risks associated with this are negligible. The participants will not have a
direct benefit from participating, but this research contributes to
improvements of surgical planning of LVB for the treatment of lymphedema.
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
• 18 years and older
• Secondary lymphedema as a result of cancer treatment,
• Secondary lymphedema of one arm or leg,
• Willingness of participation: signed informed consent
Exclusion criteria
• Presence of an allergic history for iodine,
• Patients where NIRF-L imaging cannot be performed,
• Active infection of the limb,
• Pregnancy (note: most patients will be beyond child bearing age)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78365.078.21 |
| Other | TBA |
| OMON | NL-OMON26096 |