RADIOGUIDED SURGERY IN MENINGIOMA TUMOR

Phase 1

• Conditions: SUBJECTS WITH CONVEXITY MENINGIOMA TUMORS OF NEW DIAGNOSIS; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004033-32-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-16
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Age >18, male and females
-greatest transverse lesion diameter >10mm in Brain MRI or CT scan with and without contrast agents
- diagnostic PET/CT with 68Ga-DOTATOC showing a significant uptake in the tumor (>liver) (SSR-positive tumour)
-Adequate cardiac function (ECG) and conserved hematological, liver and renal parameters
-Before the beginning of the trial, each patient will sign an informed consent
-A negative pregnancy test not older than 7 days is mandatory for women in childbearing age

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers)
- Documented contrast agents allergy
-Pregnancy/breastfeeding
- Meningioma recurrences

Study & Design

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