Investigational use of 5-ALA for fluorescence-guided resection of malignant glioma - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002606-54-IT

Enrollment

120

Registered

2006-06-05

Start date

2006-03-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Glioblastoma multiforme MedDRA version: 6.1 Level: PT Classification code 10018336

Interventions

Product Name: 5-aminolevulinic acid hydrochloride Pharmaceutical Form: Oral powder INN or Proposed INN: Aminolevulinic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Malignant glioma affected patients 2 Karnofsky Performance Scale KPS score 60 3 30 70 yera-old patients 4 informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Porphyria, renal complications, creatinine 2mg/dl, bilirubin 3mg/dl, prothrombine time 60 , gammagluthamyltransferase 70 U/L

Design outcomes

Primary

Measure	Time frame
Main Objective: Further improvement of surgical intervention by the intra-operative fluorescence-guided resection of residual malignant glioma, tested by early postoperative MR imaging;Secondary Objective: Improvement of the time to progression valued by postoperative magnetic resonance each 2 months and survival.;Primary end point(s): Residual glioma volume tested by early postoperative MR imaging 48 hours	—

Measure

Time frame

Main Objective: Further improvement of surgical intervention by the intra-operative fluorescence-guided resection of residual malignant glioma, tested by early postoperative MR imaging;Secondary Objective: Improvement of the time to progression valued by postoperative magnetic resonance each 2 months and survival.;Primary end point(s): Residual glioma volume tested by early postoperative MR imaging 48 hours

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Countries

Italy

Outcome results

None listed

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