Evaluation of Resection Quality of Cerebral Metastases Using Fluorescence Guided Surgery: a Prospective Randomised Study

NCT04116801 | Unknown Phase 4

• 1 other identifier: 2017-000515-16
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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 fluorescence guided microsurgery (fluorescein sodium) compared to the conventional microsurgical technique in the resection of cerebral metastases in adults in order to specify, by a prospective and randomised study, the assistance provided by this technique in the quality of resection and the gain in terms of overall survival and local control of brain disease.

Conditions

Cerebral Metastases; Fluorescence Guided Surgery

Outcome Measures

Primary Outcomes (1)

• Quality excision

  To evaluate the quality of excision in both neurosurgical techniques, in terms of complete resection of cerebral metastases, objectified by the absence of quantifiable tumour residues on early postoperative MRI (before 48 hours) in both groups, evaluated by one of the neuroradiologists associated with the project.

  48 hours

Study Arms (2)

Fluorescence arm

EXPERIMENTAL

fluorescence guided microsurgical resection (under 560 nm filter) in addition to the usual techniques, after iv injection of 200 mg (i.e. 3-4 mg/kg) of fluorescein sodium at the time of skin incision.

Procedure: microsurgical resection

Standard excision

ACTIVE COMPARATOR

microsurgical resection with usual techniques

Procedure: microsurgical resection

Interventions

microsurgical resection PROCEDURE

resection of cerebral metastases by microsurgery

Fluorescence arm; Standard excision

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Dr Philippe METELLUS: collaborator

Study Sites (1)

Clairval Private Hospital

Marseille, PACA, 13009, France

RECRUITING

Central Study Contacts

Jean Francois OUDET

CONTACT

+33683346567; jeanfrancois.oudet@free.fr

Marie Barba

CONTACT

+330664888704; mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: September 19, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

FR (1)