ICG alone combined with radioactivity will perform better than ICG combined with patent blue and radioactivity.
ID
Bron
Verkorte titel
Aandoening
breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Signal-to-background ratio of identified SLNs, defined as the fluorescence intensity of SLN divided by the fluorescence intensity of the surrounding background.
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. Our experimental camera system has been validated in large animal models.
In this study, randomisation will be performed between using patent blue and omitting patent blue. In all patients, ICG and radiocolloid will be used.
Doel van het onderzoek
ICG alone combined with radioactivity will perform better than ICG combined with patent blue and radioactivity.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
A Randomized Single-Institution Superiority Trial comparing standard of care SLN (radioactive tracer and blue dye) + ICG fluorescence and SLN mapping using only radiocolloid (omitting patent blue) + ICG fluorescence in breast cancer patients undergoing SLN procedure.
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)
Breast 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
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2556 |
| NTR-old | NTR2674 |
| Ander register | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |