Testing light therapy during surgery for glioblastoma
A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
This study is testing if using light therapy during surgery can help people with glioblastoma have better tumor removal and improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT04391062 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the effectiveness of escalating light doses in intraoperative photodynamic therapy (PDT) using 5-ALA-PpIX for patients with glioblastoma. The treatment aims to enhance the surgical removal of tumor tissue in conjunction with the standard treatment protocol of maximum surgical resection followed by radiochemotherapy. Patients will be monitored closely through clinical assessments and imaging to determine the therapy's impact on tumor control and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with operable glioblastoma who meet specific health criteria and can provide informed consent.
Not a fit: Patients with significant cardiopulmonary disease or those unable to adhere to the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and prolong survival for glioblastoma patients.
How similar studies have performed: Other studies have shown promise with photodynamic therapy in treating glioblastoma, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* General status (WHO) Karnofsky Performance Status ≥60
* Presumptive glioblastoma according to radiological criteria,
* Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology,
* Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting")
* Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
* Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers
* Patient able to understand and sign voluntarily Informed consent
* Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
* Women of child-bearing potential should benefit of an effective contraception
* For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
Exclusion Criteria:
* Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
* Contraindications to 5-ALA
* Porphyria
* Taking photosensitizer treatment
* Severe renal or hepatic impairment
* Bilirubin\> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)\> 2.5 x Maximum. rates
* Creatinine clearance \<30 mL / min;
* Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
* Contraindications to surgery
* Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
* Treatment with an experimental drug within 30 Days prior to the start of the study
* Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
* Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
* Pregnant or nursing women
* Refusal to participate or sign the consent of the study
* Soy allergy
Where this trial is running
Brussels and 1 other locations
- Hôpital Erasme, Clinique Universitaire de Bruxelles — Brussels, Belgium (Not_yet_recruiting)
- Hopital Roger Salengro, CHU Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Nicolas Reyns, MD,PhD — University Hospital, Lille
- Study coordinator: Nicolas Reyns, MD,PhD
- Email: nicolas.reyns@chru-lille.fr
- Phone: +33320446721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.