NCT07568782Not yet recruiting

Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers.

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

The immune system plays a critical role in cancer progression and antitumor responses. Glioblastoma is an aggressive and incurable brain tumor characterized by a highly immunosuppressive microenvironment. Over the past two decades, photodynamic therapy (PDT) has been evaluated as an adjunct to fluorescent-guided resection (FGR) and chemoradiotherapy according to the STUPP protocol, for resectable glioblastomas. In addition to demonstrating the feasibility of such a procedure, two previous clinical trials (INDYGO, NCT03048240; DOSINDYGO, NCT04391062) revealed/highlighted significant systemic immune changes following treatment, including modifications in peripheral blood mononuclear cells (PBMCs) activation and cytokine secretion profiles. However, the specific contribution of PDT remains uncertain due to the combined effects of, on the one hand, PDT and, on the other hand, FGR and chemoradiotherapy. This study aims to evaluate immune parameters in a control population undergoing FGR and chemoradiotherapy only (i.e., without PDT). The objective is to distinguish the immunological impact of PDT from that of FGR and chemoradiotherapy. The results will provide a better understanding of the systemic immune modulation induced by PDT in glioblastoma.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 17 (estimated)
First submitted: 28 Apr 2026
Start date: Oct 2026
Primary completion date: Apr 2028
Lead sponsor: University Hospital, Lille
Diseases: Glioblastoma
NCT number: NCT07568782

What you commit to

Study type: Observational
Planned participants: 17
From Oct 2026 to the primary completion date, Apr 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Contraindications to surgery
Treatment with an experimental drug within 30 Days prior to the start of the study

Other illness

Soy allergy

Lab values

Contraindications to 5-ALA (Gliolan®)
- 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

Other

Contraindications to magnetic resonance imaging (MRI)
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

Who the study is looking for

Patient male or female ≥18 years
General status (WHO) of Performance status 0, 1 or 2
Probable glioblastoma according to clinical and radiological criteria,
whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
Decision to treat the patient as part of the Clinical trial also taken 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 scheduled at the hospital CHRU of Lille, center of reference of the region
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
Patient assigned to an health insurance

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
CHU Lille Coordinator of this site? Confirm its status	Lille	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.