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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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