Study the concordance rate of SLN identified using MSOT and ICG versus the standard of care with Tc99m and lymphoscintigraphic imaging.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard
of care with Tc99m and lymphoscintigraphic imaging
- Number of sentinel lymph nodes visualized with MSOT
- Number of sentinel lymph nodes visualized with lymphoscintigraphy
- Positive detection of ICG on the SLN specimen visualized with an ex vivo
fluorescence imaging device
Secondary outcome
n/a
Background summary
Over the past few decades, melanoma has been one of the fastest-growing cancers
and the incidence rate of melanoma is still increasing. Standard treatment for
melanoma is wide (re)excision. Sentinel lymph node (SLN) biopsy (SLNB) is
recommended for patients with melanoma of AJCC stage pT1b or higher according
to Dutch guidelines. SLNB provides essential staging information that impacts
on the clinical management of patients with melanoma, and the presence of SLN
metastasis indicates a significantly worse prognosis. However, the overall
complication rate of SLNB is high.
Currently, lymphoscintigraphy using Technetium-99m-nanocolloïd (Tc99m) is the
gold standard to identify the sentinel lymph node. However, there are various
disadvantages of using Tc99m: the involvement of radioisotopes represents a
radioactive burden for patients and caregivers, the lymphoscintigraphic imaging
has poor spatial resolution, and the involvement of radioisotopes is expensive
and creates logistic challenges. Therefore, in this study the goal is to
identify the sentinel lymph node in a non-invasive manner without the use of a
radioactive tracer. We try to reach this goal by using the fluorophore dye
IndoCyanine Green (ICG) and multispectral optoacoustic imaging (MSOT).
Study objective
Study the concordance rate of SLN identified using MSOT and ICG versus the
standard of care with Tc99m and lymphoscintigraphic imaging.
Study design
A technical feasibility, non-randomized, open label, single group proof of
concept study.
Study burden and risks
Patients who participate will receive one more intradermal peritumoral
injection and undergo 2 MSOT imaging moments (+/- 15-30 minutes). The overall
risk of this study is therefore considered low. There are no direct benefits
for patients participating in this study.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Scheduled for SLNB
Exclusion criteria
- Serious medical conditions which make inclusion in a clinical trial not
favourable as decided by the surgeon
- Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland
- Prior surgery or radiotherapy on involved lymph nodes / area
- Major surgery within 28 days before tracer administration
- Pregnant or nursing women, fertile women will need a negative pregnancy test
prior to inclusion
- History of iodine allergy or anaphylactic reactions to insect bites
- Skin type >IV following Fitzpatrick skin classification (MSOT less reliable)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79275.042.21 |