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van CCT (UK)

van CCT (UK)

Intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.

- candidate number6675
- NTR NumberNTR2084
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2009
- Secondary IDsCME Leiden P09.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.
- Scientific TitleIntra-operative fluorescent imaging of sentinel lymph nodes in breast cancer.
- hypothesisFluorescent near-infrared imaging can accurately detect lymph nodes percutaneously and non-invasively during SLNP in breast cancer patients.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaBreast cancer patients planned to undergo a sentinel lymph node procedure.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jan-2009
- planned closingdate11-jan-2011
- Target number of participants53
- InterventionsStandard 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.
- Primary outcomeIdentification 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 outcome1. 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.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Leiden University Medical Center (LUMC), Center for Translational Molecular Medicine (CTMM), American Women's Club, Maurits en Anne de Kock Stichting
- PublicationsN/A
- Brief summaryAlthough 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.
- Main changes (audit trail)
- RECORD28-okt-2009 - 3-jan-2011

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