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Laparoscopische Intra-operatieve fluorescente beeldvorming van oogmelanoom lever metastasen.

Laparoscopic Near-Infrared Fluorescence Imaging of Hepatic Uveal Melanoma Metastases.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22421
Enrollment
15
Registered
2013-02-21
Start date
2012-09-01
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

Hepatic Uveal Melanoma Metastases

Interventions

ICG will be administered 24hours before surgery. During laparoscopic surgery, liver metastases will be visualised using near-infrared fluorescence imaging and standard liver resection will be performe

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with uveal melanoma liver metastasis that are eligible for resection; 2. Age between 18 and 80 years old.

Exclusion criteria

Exclusion criteria: 1. No history of allergy to iodine, shellfish, indocyanine green, human serum albumin and/or history of hyperthyroidism or severe renal impairment; 2. Patient pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
Feasiility of Intra-operative identification of liver metastases.

Secondary

MeasureTime frame
Identification rate; defined as the number of tumours that were identified with the fluorescent signal of ICG during operation, compared with the number of microscopically Tumor to background ratio between different doses of ICG injected and different time intervals injected.

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)