RADIOGUIDED SURGERY IN MENINGIOMA TUMOR

AN OPEN, MONOCENTRIC, NOT CONTROLLED CLINICAL TRIAL TO DEVELOP AND EVALUATE THE CLINICAL APPLICATION OF A NEW BETA PROBE FOR RADIOGUIDED SURGERY IN MENINGIOMA TUMOR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004033-32-IT

Enrollment

Registered

2013-10-16

Start date

2013-12-13

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SUBJECTS WITH CONVEXITY MENINGIOMA TUMORS OF NEW DIAGNOSIS

Interventions

Product Name: 90Y-Dotatoc (DOTA-D-Phe-Tyr-OCTREOTIDE) Product Code: 90 Y-Dotatoc Pharmaceutical Form: Solution for injection INN or Proposed INN: OCTREOTIDE CAS Number: 83150-76-9 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Toassess feasibility, specificity and sensibility of the probe during meningioma surgery;Secondary Objective: NOT APPLICABLE;Primary end point(s): Evaluation of sensibility and specifity of the probe to detect the radiotracer up-take during intracranial convexity meningioma surgery;Timepoint(s) of evaluation of this end point: T0 and T36	—

Secondary

Measure	Time frame
Secondary end point(s): - To minimize the delivered radiation dose. - To evaluate the residual radiations modifying the dose injected - To evaluate the radiation exposure of the personnel - To optimized probe - Toxicity;Timepoint(s) of evaluation of this end point: During all the period of study	—

Countries

Italy

Contacts

Public ContactRENATO MANTEGAZZA

FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA

crc@istituto-besta.it+390223942321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026