ICG combined with 99Tc-Nanocoll can be used as fluorescent tracer in sentinel lymph node mapping in vulvar cancer patients.
ID
Bron
Verkorte titel
Aandoening
Vulvar cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The proportion of patients in whon sentinel and non-sentinel lymph nodes can be identified;<br>
2. Difference in signal-to-background ratio between different injection groups.
Achtergrond van het onderzoek
Although sentinel lymph node procedure (SLNP) is regarded standard of care, the technique is not optimal and it requires involvement of ionizing radiation. Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes. In previous experiment we succesfully identifies SLNs with fluorescent imaging. In this study, a combined fluorescent and radioactive probe is used for SLN identification.
Doel van het onderzoek
ICG combined with 99Tc-Nanocoll can be used as fluorescent tracer in sentinel lymph node mapping in vulvar cancer patients.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
Standard SLNP will be performed. One day before surgery or the day of surgery. 99TC-Nanocoll-ICG will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively and percutaneously using our experimental camerasystem during surgery.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Vulvar cancer patients planned to undergo a sentinel lymph node procedure.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3679 |
| NTR-old | NTR3849 |
| Ander register | METC Leiden : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |