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Intra-operatieve fluorescente beeldvorming van levertumoren.

Intra-operative identification of colorectal liver metastasis or hepatocellular carcinoma using indocyanin green nearinfrared fluorescence.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22776
Enrollment
12
Registered
2010-02-12
Start date
2010-02-01
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

Liver cancer, Liver tumor, colorectal liver metastases, hepatocellular carcinoma.

Interventions

Standard liver resection will be performed. After mobilization, the near-infrared dye ICG will be injected i.v. and liver tumors will be visualized non-invasively and using our experimental camerasyst

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with colorectal cancer liver metastasis or hepatocellular carcinoma 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
Intra-operative 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 confirmed tumours.

Secondary

MeasureTime frame
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)