No registrations found.
ID
Source
Brief title
Health condition
Melanoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
NIR fluorescence identification ratio of the SLN, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes were identified using NIR fluorescence.
Secondary outcome
1. Signal to background ratio of the SLNs;
2. Number of identified SLNs: fluorescence a nd non-fluorescence;
3. In vivo and ex vivo fluorescence intensity of SLNs and radioactivity of the SLNs;
4. Percutaneous lymphatic channel identification at multiple time points;
5. Time to identification of SLN.
Background summary
Combining radioactive colloids and a near-infrared fluorophore permits both preoperative planning and intraoperative localization of deeply located sentinel lymph nodes (SLNs) with direct optical guidance using a single lymphatic tracer. This study aims to evaluate and optimize a hybrid NIR fluorescence and radioactive tracer for SLN detection in melanoma patients.
Study objective
A tracer coctail combining indocyanine green and radioactive colloids will allow enhanced detection of the sentinel lymph node in melonoma patients.
Study design
The primary and secondary outcomes will be assessed during lymphoscintigraphy, surgery and pathological assessment.
Intervention
A feasibility single-institution trial to assess the use of ICG combined with 99mTc-nanocolloid as a cocktail in SLN mapping in melanoma patients. Standard-of-care SLN mapping will be performed (blue dye staining and radiocolloid).
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Inclusion criteria
Melanoma patients planned to undergo a sentinel lymph node procedure.
Exclusion criteria
1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin;
2. Pregnancy;
3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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 |
|---|---|
| NTR-new | NL3680 |
| NTR-old | NTR3850 |
| Other | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |