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Intraoperatieve fluorescente beeldvorming van hypofyse adenomen met indocyanine groen.

Real-time intraoperative fluorescence imaging of pitiutary adenomas using Indocyanine green.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21008
Enrollment
20
Registered
2012-10-09
Start date
2012-05-01
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

Pituitary adenomas

Interventions

Standard pituitary adenoma resection will be performed. Just before the actual resection, indocyanine green will be injected intravenously to identify the pituiraty adenoma using NIR fluorenscence.

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnoses with pitiutary adenoma, planned for resection; 2. Age between 18 and 80 years old.

Exclusion criteria

Exclusion criteria: 1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin; 2. Pregnancy; 3. Hyperthyroidism; 4. Severe renal impairement; 5. 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
Intra-operative identification rate, defined as the number of adenomas that were identified with the fluorescent signal of indocyanine green during operation.

Secondary

MeasureTime frame
Tumor-to-background signal of the identified adenomas.

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)