Light measurements during brain tumor operation in children

Optical measurement with 5-ALA during surgical resection of brain tumors in children - OTP-Children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005565-40-SE

Enrollment

Registered

2014-02-17

Start date

2014-09-11

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

Tumour border by means of fluorescenstechnique during surgical resection of brain tumours.

Interventions

Trade Name: Gliolan Product Name: Gliolan Pharmaceutical Form: Concentrate for oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 3-17 years. Planned or acute brain tumour surgery. Patiens with new radiologal findings of infiltative infra- and supratentorial brain tumours. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Oversensitivity to 5-ALA or porphyria Acute or chronic porphyria Pregnacy Breast feeding Liver, kidney and bloodvalues deviation more than +/-10% from reference values before surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: Improve brain tumour resection in children. ;Secondary Objective: Use fluorescence techniques (imaging and point measurements) for finding tumour border during resection. Compare fluorescence recordings in the microscope and point measurements with histology and other imaging techniques used (e.g. MRI, ultrasound), and naked eye assessment by the surgeon. ;Primary end point(s): The fluorescense microscopy increase the possibility to identify the tumour margins during tumour resection. The probe technology detect weak fluorescence better than the microscope in the tumour and tumour border zone. ;Timepoint(s) of evaluation of this end point: During surgery.	—

Measure

Time frame

Main Objective: Improve brain tumour resection in children. ;Secondary Objective: Use fluorescence techniques (imaging and point measurements) for finding tumour border during resection. Compare fluorescence recordings in the microscope and point measurements with histology and other imaging techniques used (e.g. MRI, ultrasound), and naked eye assessment by the surgeon. ;Primary end point(s): The fluorescense microscopy increase the possibility to identify the tumour margins during tumour resection. The probe technology detect weak fluorescence better than the microscope in the tumour and tumour border zone. ;Timepoint(s) of evaluation of this end point: During surgery.

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Secondary

Measure	Time frame
Secondary end point(s): The fluorescens intensity recorded by the probe is objectified and calculated as a number displaying the strength. The number is especially helpful in the borderzon, compared to the microscope. The fluorescence strength and the biopsy results agree and can be devided into groups representing different tissue types. The resected volume as calculated from the MRI is related to the clinical outcome of the operation. ;Timepoint(s) of evaluation of this end point: Postoperatively within three months after surgery.	—

Measure

Time frame

Secondary end point(s): The fluorescens intensity recorded by the probe is objectified and calculated as a number displaying the strength. The number is especially helpful in the borderzon, compared to the microscope. The fluorescence strength and the biopsy results agree and can be devided into groups representing different tissue types. The resected volume as calculated from the MRI is related to the clinical outcome of the operation. ;Timepoint(s) of evaluation of this end point: Postoperatively within three months after surgery.

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Countries

Sweden

Contacts

Public ContactLinköping University

Department of Biomedical Engineering

neda.haj.hosseini@liu.se46101032488

Outcome results

None listed

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