/A

• Conditions: Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor; MedDRA version: 14.1Level: HLGTClassification code 10039911Term: Seizures (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-006301-10-ES
• Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and females older than 18 years.
-Undergoing supratentorial parenchyma resection surgery.
-Capable of collaborate on probes and explorations included in the study.
-Signature the written informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Life expectancy less than 12 months due to the suspected histological type of tumour.
- Hypothalamic-pituitary axis illness.
- Presence of Melanoma previously.
- Glomerular filtration rate less than 60 mL/min.
- Thyroid or parathyroid glands pathology.
- Myasthenia gravis.
- Respiratory depression.
- Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified