Evaluation of fluoroscein as contrast medium for glioma surgery

Glioma lesions outlining with optics modification assistance: a phase II trial evaluating fluorescein-aided glioblastoma surgery - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003402-16-IT

Enrollment

Registered

2020-11-04

Start date

2015-11-06

Completion date

Unknown

Last updated

2021-01-11

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

Conditions

Glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: FLUORESCEINA SODICA MONICO - 1G/5ML SOLUZIONE INIETTABILE PER USO ENDOVENOSA 10 FIALE Product Name: Fluoresceina sodica Product Code: NA Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Have given written informed consent to participate • Be aged 18 years and over • Suspected diagnosis of High Grade Glioma on pre-op (=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Known allergy to contrast media • Pregnancy • Renal failure (creatinine > 1.5 mg/dL)

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Within 72 hours after surgery;Main Objective: Improve the rate of success of surgical interventions on GMB maximizing the resection and minimizing the unnecessary damage.;Secondary Objective: Evaluate the Progression Free survival of the patients, the Overall Survival, the advent of new neurological deficits and the quality of life of the patients.;Primary end point(s): The rate of GTR on post op c.e. Radiological assesments	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Within 72 hours after surgery;Main Objective: Improve the rate of success of surgical interventions on GMB maximizing the resection and minimizing the unnecessary damage.;Secondary Objective: Evaluate the Progression Free survival of the patients, the Overall Survival, the advent of new neurological deficits and the quality of life of the patients.;Primary end point(s): The rate of GTR on post op c.e. Radiological assesments

—

Secondary

Measure	Time frame
Secondary end point(s): Progression free survival (PFS); Overall survival; Neurological performances and quality of life;Timepoint(s) of evaluation of this end point: End of study; End of study; End of study	—

Countries

Italy

Contacts

Public ContactStruttura di neurochirurgia

Fondazione IRCCS Policlinico San Matteo

p.gaetani@smatteo.pv.it+390382502474

Outcome results

None listed

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