No registrations found.
ID
Source
Brief title
Health condition
breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Signal-to-background ratio of identified SLNs, defined as the fluorescence intensity of SLN divided by the fluorescence intensity of the surrounding background.
Secondary outcome
1. Number of identified SLNs: fluorescence and non-fluorescence;
2. In vivo and ex vivo fluorescence intensity of SLNs;
3. Identification ratio;
4. Percutaneous lymphatic channel identification;
5. Time to identification of SLN.
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.
In this study, randomisation will be performed between using patent blue and omitting patent blue. In all patients, ICG and radiocolloid will be used.
Study objective
ICG alone combined with radioactivity will perform better than ICG combined with patent blue and radioactivity.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
A Randomized Single-Institution Superiority Trial comparing standard of care SLN (radioactive tracer and blue dye) + ICG fluorescence and SLN mapping using only radiocolloid (omitting patent blue) + ICG fluorescence in breast cancer patients undergoing SLN procedure.
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 | NL2556 |
| NTR-old | NTR2674 |
| Other | METC LUMC : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |