FG001 in subjects with Meningiomas or presumed Low-Grade Gliomas scheduled for neurosurgery

Phase 1

• Conditions: Meningioma and lowgrade glioma; MedDRA version: 21.1Level: PTClassification code 10027191Term: MeningiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10018338Term: GliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2023-000163-31-DK
• Lead Sponsor: Copenhagen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subjects diagnosed with primary brain tumor on MRI suggestive of primary meningioma or presumed low-grade glioma (pLGG)*
2. Scheduled for neurosurgery with the objective to remove cancer tissue
3. Subjects 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 subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit.
7. Subject must not previously have received the trial drug (FG001)
8. Subjects 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Any known allergy or hypersensitivity to indocyanine green (ICG)
2. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion (or if breast-feeding willing to pause breast feeding during trial and for 30 days
3. Overall performance status or co-morbidity deeming the subject 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

Study & Design

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