Status:
UNKNOWN
Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study
Lead Sponsor:
Ramsay Générale de Santé
Collaborating Sponsors:
Dr Philippe METELLUS
Conditions:
Cerebral Metastases
Fluorescence Guided Surgery
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Few studies have evaluated the use of fluorescein sodium for the resection of brain tumours (especially glioblastomas) but also cerebral metastases. We therefore propose to evaluate the technique of f...
Detailed Description
Cerebral metastases are a major public health problem in cancer patients. They are the most common brain tumours in adults. It is estimated that approximately 20-40% of patients with primary malignant...
Eligibility Criteria
Inclusion
- Male or female subject over the age of 18 and under the age of 85
- Subject presenting 1 to 5 cerebral secondary locations of which one lesion (contrast enhancement of at least 1 cm) is accessible to the most complete excision possible
- Unprotected adult within the meaning of the law
- Subject belonging to a health insurance scheme
- Absence of medical contraindications to surgery and anaesthesia
- Absence of medical contraindications to performing an MRI
- Known absence of allergy to the injectable form of Fluorescein sodium
- Subject having signed their written informed consent.
Exclusion
- Subject who is a minor, pregnant, parturient or breastfeeding woman
- Adult subject under legal protection, guardianship or deprivation of liberty by judicial or administrative decision
- Subject hospitalised without consent
- Anatomical localisation (cerebral trunk, diencephalon) of the cerebral metastasis counter-indicating a wide excision at the discretion of the neurosurgeon
- Subject participating in a clinical trial or any other research involving human beings
- Subject taking beta-blockers
- Subject who has not signed a written informed consent.
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04116801
Start Date
September 19 2017
End Date
September 30 2020
Last Update
October 7 2019
Active Locations (1)
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1
Clairval Private Hospital
Marseille, PACA, France, 13009