Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers. (SHAM INDYGO/DO)

April 28, 2026 updated by: University Hospital, Lille
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nadira Pr DELHEM, PU

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with newly diagnosed resectable glioblastoma undergoing fluorescence-guided resection and chemoradiotherapy according to the STUPP protocol. The study includes a prospective control cohort treated with fluorescence-guided resection and chemoradiotherapy only (i.e., without photodynamic therapy (PDT)) and a historical prospective cohort previously treated with intraoperative PDT (INDYGO and DOSINDYGO trials) combined with fluorescence-guided resection and chemoradiotherapy. All patients receive standard post-operative Stupp protocol. Peripheral blood samples are analyzed for systemic immune profiling.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Contraindications to surgery
  • Contraindications to magnetic resonance imaging (MRI)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control No PDT
17 patients with resectable glioblastoma undergoing FGR and chemoradiotherapy only (i.e., without PDT). These patients are matched 1:1 by age and sex with patients from the completed INDYGO (NCT03048240) and DOSINDYGO (NCT04391062) trials who underwent immunological analysis (6 INDYGO patients and 11 DOSINDYGO patients).
Procedure: Fluorescence-guided resection (FGR)
Patients undergo fluorescence-guided resection for glioblastoma. Post-operative management includes standard radiochemotherapy according to the STUPP protocol. Peripheral blood samples are collected longitudinally for immunological analyses (PBMCs, immune activation markers, cytokine profiling). This group serves as a matched control cohort for patients in the INDYGO and DOSINDYGO trials who received PDT in addition to FGR and chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of systemic immune response over 6 months following fluorescence-guided resection and during chemoradiotherapy
Time Frame: From baseline (pre-surgery) to 6 months post-surgery
Systemic immune response will be assessed by longitudinal changes in the proportion of circulating immune cell subsets quantified by flow cytometry and by cytokine concentrations measured through secretome analysis. All measurements will be analyzed as variations relative to a pre-operative baseline to evaluate immune modulation following resection and during chemoradiotherapy.
From baseline (pre-surgery) to 6 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of immune cells transcriptomic profile
Time Frame: From baseline (pre-surgery) to 6 months post-surgery
Changes in exosome-induced immune cell proliferation are assessed in peripheral blood samples. The immunomodulatory effects of circulating exosomes are evaluated through their capacity to induce proliferation of immune cells over time following surgical resection and during chemoradiotherapy.
From baseline (pre-surgery) to 6 months post-surgery
Immunomodulatory effects of circulating exosomes following glioblastoma resection and during chemoradiotherapy
Time Frame: From baseline (pre-surgery) to 6 months post-surgery
Changes in exosome-induced immune cell proliferation are assessed in peripheral blood samples. The immunomodulatory effects of circulating exosomes are evaluated through their capacity to induce proliferation of immune cells over time following surgical resection and during chemoradiotherapy.
From baseline (pre-surgery) to 6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Lille University

Investigators

  • Principal Investigator: Nicolas REYNS, PU-PH, Chu Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

June 15, 2028

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024_0446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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