Multi-center trial of FG001 in patients with malignant brain tumour scheduled for neurosurgery.

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003089-38-SE
• Lead Sponsor: FluoGuide A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Patients diagnosed with tumor specific contrast enhancement on MRI suggestive of malignant glioblastoma - primary .
2. Scheduled for neurosurgery with the objective to take biopsy, grading or remove cancer tissue
3. Patients aged 18 years or older
4. Capable of understanding and giving written informed consent
5. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
6. Male patients must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit
7. Patient must not previously have received the trial drug (FG001)
8. Patients can only be included if the surgery is planned to be guided by 5-ALA.
9. Patients can only be included if the scheduled surgery is anticipated gross total resection (GTR) with the objective to remove cancer tissue
10. Patients must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Any known allergy or hypersensitivity to indocyanine green (ICG)
2. Female patients who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
3. Overall performance status or co-morbidity deeming the patient unfitted for participation in the trial as judged by the Investigator
4. Pre-existing hepatic and/or renal insufficiency
- INR > 1,7
- Estimated GFR (eGFR) <45 ml/min/1,73m2
5. Unwilling or unable to follow the protocol requirements
6. History of allergic reactions attributed to compounds of similar chemical/biologic composition to 5-ALA
7. Known or documented personal or family history of porphyria
8. Prior history of serious gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease
9. Simultaneous participation in another clinical trial receiving a trial drug
10. Simultaneous use of other potentially phototoxic substances (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing 5-ALA for 24 hours during the perioperative period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified