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Intra-operatieve fluorescente beeldvorming van schildwachtklieren bij baarmoederhalskankerpatienten.

Intra-operative fluorescent imaging of sentinel lymph nodes in cervical cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22239
Enrollment
12
Registered
2010-08-25
Start date
2010-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

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 visu

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cervical cancer patients planned to undergo a lymphadenectomy.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Median number of lymph nodes identified with ICG:HSA.

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)