No registrations found.
ID
Source
Brief title
Health condition
Hepatic Uveal Melanoma Metastases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasiility of Intra-operative identification of liver metastases.
Secondary outcome
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.
Background summary
One of the main challenges in liver surgery for uveal liver metastasis is intraoperative tumor detection. Especially intra-operative detection of small tumors has proven to be very difficult. Near-infrared fluorescent (NIRF) imaging is a recently developed method to visualize tumor tissue during surgery. Standard liver resection will be performed. The near-infrared dye ICG will be injected i.v. and liver tumors will be visualized using a laparoscopic NIRF imaging system.
Study objective
Laparoscopic Fluorescent near-infrared imaging using ICG can accurately detect liver metastases from uveal melanoma intra operatively.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
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 performed.
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
1. Patients diagnosed with uveal melanoma liver metastasis that are eligible for resection;
2. Age between 18 and 80 years old.
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
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 | NL3700 |
| NTR-old | NTR3869 |
| Other | METC LUMC : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |