No registrations found.
ID
Source
Brief title
Health condition
Cervical cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Median number of lymph nodes identified with ICG:HSA.
Background summary
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.
Study objective
Fluorescent near-infrared imaging can accurately detect sentinel lymph nodes non-invasively during lymphadenectomy in cervical cancer patients.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
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.
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
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
Inclusion criteria
Cervical cancer patients planned to undergo a lymphadenectomy.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2373 |
| NTR-old | NTR2480 |
| Other | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |