Glioblastoma photodynamic therapy

Phase 1

• Conditions: Glioblastoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004796-40-FR
• Lead Sponsor: CHU de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Patient male or female age =18 years
2. Free and informed consent of the patient with signature of the consent form participation in the study after submission of the information note.
3. General health status - Karnofsky score =60
4. Probable glioblastoma according to clinical criteria and MRI whose indication of surgical load was posed in CPR neuro-oncology.
5. Decision to treat the patient as part of the clinical trial also taken in CPR neuro-oncology
6. Patient operable on the basis of absence of cardiopulmonary history, or balance sheet providing sufficient post-operative status for normal daily life.
7. Clinical neuro-oncological follow-up and MRI (T1, T1 Gado, T2, FLAIR) at long planned course in the participating center.
8. Patient able to understand the briefing note, to voluntarily sign a informed consent and to adhere to the study program for the study and to others imperatives of the protocol.
9. Effective contraception for women of childbearing age to avoid pregnancy during the study.
10. For patients receiving long-term hepatotoxic treatment, this treatment must be able to be hung for 24 hours after taking 5-ALA
11. Quality of social insurance or social security entitlement
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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

1. Contraindications to 5-ALA or intraoperative PDT
2. Legal incapacity (persons deprived of their liberty or under guardianship or curatorship)
3. Contraindications to MRI and / or TEP 11C MET
4. Treatment with an experimental drug in the 30 days prior to the start of the study,
5. Clinical follow-up impossible for psychological, family, social or geographical reasons,
6. Pregnant or lactating woman
7. Refusal to participate or sign consent
8. Soy Allergy

Study & Design

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