Fluorescent near-infrared imaging can accurately detect sentinel lymph nodes non-invasively during lymphadenectomy in cervical cancer patients.
ID
Bron
Verkorte titel
Aandoening
Cervical cancer
Ondersteuning
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 with the fluorescent signal of ICG:HSA.
Achtergrond van het onderzoek
Although sentinel lymph node procedure (SLNP) is not regarded standard of care, the technique can potentially be implemented in cervical cancer patients. 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.
Doel van het onderzoek
Fluorescent near-infrared imaging can accurately detect sentinel lymph nodes non-invasively during lymphadenectomy in cervical cancer patients.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Onderzoeksproduct en/of interventie
Standard lymphadenectomy will be performed. Before median laparotomy, the near-infrared dye ICG:HSA will be injected peritumorally around the cervix and lymphatic pathways and lymph nodes will be visualized non-invasively 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)
Cervical cancer patients planned to undergo a lymphadenectomy.
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 | NL2373 |
| NTR-old | NTR2480 |
| Ander register | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |