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

An open-label, non-randomized, single dose, phase II trial of FG001 (an optical imaging agent) for localization of Meningiomas or presumed Low-Grade Gliomas scheduled for neurosurgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000163-31-DK

Enrollment

Registered

2023-02-24

Start date

2023-03-27

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningioma and lowgrade glioma MedDRA version: 21.1 Level: PT Classification code 10027191 Term: Meningioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: FG001 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: Not available Current Sponsor code: FG001 Other descriptive name: FG001 sodium Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).;Secondary Objective: - To evaluate the pharmacokinetics profile of single dose FG001 - To evaluate safety and tolerability ;Primary end point(s): - Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.;Timepoint(s) of evaluation of this end point: The sensitivity will be evaluated as the proportion of subjects with fluorescent tumors given the tumor has been histologically verified. The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity and specificity, which is verified via the intensity of fluorescence from the specimen taken.	—

Measure

Time frame

Main Objective: - To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).;Secondary Objective: - To evaluate the pharmacokinetics profile of single dose FG001 - To evaluate safety and tolerability ;Primary end point(s): - Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.;Timepoint(s) of evaluation of this end point: The sensitivity will be evaluated as the proportion of subjects with fluorescent tumors given the tumor has been histologically verified. The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity and specificity, which is verified via the intensity of fluorescence from the specimen taken.

—

Secondary

Measure	Time frame
Secondary end point(s): a. Efficacy - Demonstrate exposure of FG001 b. Safety and tolerability - Adverse Events - Laboratory parameters - 12 - lead ECG parameters - Vital Signs ;Timepoint(s) of evaluation of this end point: Pharmacokinetics (PK) will be sampled (after FG001 has been administered), at the following timepoints: 1 hours and prior to the surgery. Whole blood samples should be centrifuged as soon as possible after collection, frozen and shipped to the PK laboratory (Labcorp Laboratories Limited, Huntingdon, UK) as described in the Laboratory Manual. Analysis of the samples for PK will be done in batches.	—

Measure

Time frame

Secondary end point(s): a. Efficacy - Demonstrate exposure of FG001 b. Safety and tolerability - Adverse Events - Laboratory parameters - 12 - lead ECG parameters - Vital Signs ;Timepoint(s) of evaluation of this end point: Pharmacokinetics (PK) will be sampled (after FG001 has been administered), at the following timepoints: 1 hours and prior to the surgery. Whole blood samples should be centrifuged as soon as possible after collection, frozen and shipped to the PK laboratory (Labcorp Laboratories Limited, Huntingdon, UK) as described in the Laboratory Manual. Analysis of the samples for PK will be done in batches.

—

Countries

Denmark

Contacts

Public ContactAndreas Kjær

Copenhagen University

akjaer@sund.ku.dk4527258614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026