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Completed

NCT Number: NCT03048240

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

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 heath insurance

Exclusion criteria

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

Treatment and study plan

"perPDT"

Device

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).

GLIOLAN

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Response to treatment

    Time frame: From the date of perPDT until relapse/death, assessed up to 24 months

    Evaluated by MRI every 3 months

  4. 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.

  5. 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.

  6. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study title

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

Acronym: INDYGO

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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