No registrations found.
ID
Source
Brief title
Health condition
Breast cancer
Borstkanker
Sponsors and support
Additional funding from:
CTMM
American Women's Club
ZonMw
Maurits en Anne de Kock Stichting
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
1. Median number of lymph nodes identified with ICG:HSA and standard SNB;
2. Identification rate of standard SNB;
3. Sensitivity: percentage of patients in whom fluorescent lymph nodes were identified of the total patients with identified sentinel lymph nodes by standard SNB technique;
4. Improvement in false-negative rate.
Background summary
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.
Study objective
Fluorescent near-infrared imaging can accurately detect lymph nodes percutaneously and non-invasively during SLNP in breast cancer patients.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
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.
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
Breast cancer patients planned to undergo a sentinel lymph node procedure.
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 | NL1967 |
| NTR-old | NTR2084 |
| Other | METC LUMC : CME Leiden P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |