INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)

University Hospital, Lille

Status: Completed

Conditions: Glioblastoma

Treatments: Drug: GLIOLAN; Device: "perPDT"

Study type: Interventional

Funder types: Other

Identifiers

NCT03048240

2016-002706-39 (EudraCT Number)

2016_06

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

"perPDT"

Experimental group

Description:

Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.

Treatment:

Device: "perPDT"

Drug: GLIOLAN