INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)

February 2, 2026 updated by: University Hospital, Lille

A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.

The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Lille, France
        • Hôpital Roger Salengro, CHRU

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient male or female ≥18 years
  2. General status (WHO) of Performance status 0, 1 or 2
  3. Probable glioblastoma according to clinical and radiological criteria,
  4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
  5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
  6. 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
  7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
  8. Patient able to understand and sign voluntarily Informed consent
  9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
  10. Women of child-bearing potential should benefit of an effective contraception
  11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
  12. Patient assigned to an heath insurance

Exclusion Criteria:

  1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":

  2. 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
  3. Contraindications to surgery
  4. Contraindications to magnetic resonance imaging (MRI)
  5. Treatment with an experimental drug within 30 Days prior to the start of the study
  6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
  7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
  8. Pregnant or nursing women
  9. Refusal to participate or sign the consent of the study
  10. 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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "perPDT"
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
Device: "perPDT"

The protocol requires the realization of specific procedures in addition to the usual care.

The per-operative photodynamic therapy ("perPDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).

Drug: GLIOLAN
patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0
Time Frame: From the intake of Gliolan (5-Ala) until 1 month post "perPDT"

In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period.

Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities
From the intake of Gliolan (5-Ala) until 1 month post "perPDT"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months
Determined according to international RANO criteria
From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months
Overall Survival (OS)
Time Frame: From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months
Determined according to international RANO criteria
From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months
Response to treatment
Time Frame: From the date of perPDT until relapse/death, assessed up to 24 months
Evaluated by MRI every 3 months
From the date of perPDT until relapse/death, assessed up to 24 months
Incidence of "per PDT" treatment-emergent Adverse Events
Time Frame: From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months
Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.
From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months
Quality of Life Questionnaire -C30 ( QLQ-C30)
Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Measuring the health-related quality of life in patients with brain cancer
Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months

Other Outcome Measures

Outcome Measure
Time Frame
Analyze of Peripheral Blood Mononuclear Cells
Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Nicolas Reyns, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 5, 2017

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

April 28, 2021

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_06
  • 2016-002706-39 (EudraCT Number)

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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