A tracer coctail combining indocyanine green and radioactive colloids will allow enhanced detection of the sentinel lymph node in breast cancer patients.
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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 breast cancer patients.
Doel van het onderzoek
A tracer coctail combining indocyanine green and radioactive colloids will allow enhanced detection of the sentinel lymph node in breast cancer patients.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during lymphoscintigraphy, surgery and pathological assessment.
Onderzoeksproduct en/of interventie
A feasibility single-institution trial to assess the use of ICG combined with 99mTc-nanocolloid as a cocktail in SLN mapping in breast cancer patients. Standard-of-care SLN mapping will be performed (blue dye staining and radiocolloid).
Two groups will be formed. Both groups will receive different dose of 99mTc-nanocolloid.
Algemeen / deelnemers
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
Wetenschappers
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
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3531 |
| NTR-old | NTR3685 |
| Ander register | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |