Fluorescent near-infrared imaging can accurately detect lymph nodes percutaneously and non-invasively during SLNP in breast cancer patients.
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Borstkanker
Ondersteuning
Additional funding from:
CTMM
American Women's Club
ZonMw
Maurits en Anne de Kock Stichting
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Identification rate, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified percutaneously with the fluorescent signal of ICG:HSA
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.
A phase I single-institution feasibility trial followed by a phase II non-randomized,
open-label, single-institution diagnostic efficacy trial if proven feasible in detecting
axillary lymph nodes in humans during phase I.
Doel van het onderzoek
Fluorescent near-infrared imaging can accurately detect lymph nodes percutaneously and non-invasively during SLNP in breast 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. Before axillary incision, the near-infrared dye
ICG:HSA will be injected and lymphatic pathways and lymph nodes will be visualized
non-invasively and percutaneously using our experimental camerasystem.
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
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1967 |
| NTR-old | NTR2084 |
| Ander register | METC LUMC : CME Leiden P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |