FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

NCT06684795 | Recruiting Phase 2 DMC

• 1 other identifier: RH-FG001-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.

Conditions

Low-grade Glioma; Meningioma; Glioma

Outcome Measures

Primary Outcomes (1)

• Primary objective

  The primary objective is to evaluate the sensitivity of FG001 for detection of tumor tissue from meningioma and pLGG. The sensitivity will be evaluated as the proportion of subjects with fluorescent tumors given the tumor has been histologically verified.

  24 months

Secondary Outcomes (1)

• Secondary outcome

  24 months

Study Arms (2)

Presumed low-grade glioma

EXPERIMENTAL

Drug: FG001 prior to surgery

Meningioma

EXPERIMENTAL

Drug: FG001 prior to surgery

Interventions

FG001 prior to surgery DRUG

Patients will receive a single intravenous injection of 36 mg FG001 administered the day before surgery.

Meningioma; Presumed low-grade glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be entered into this trial only if they meet all the following criteria:
• Subjects diagnosed with primary brain tumor on MRI suggestive of, meningioma or presumed low-grade glioma (pLGG)\*
• Scheduled for neurosurgery with the objective to remove cancer tissue
• Subjects aged 18 years or older
• Capable of understanding and giving written informed consent
• 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)
• Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit.
• Subject must not previously have received the trial drug (FG001)
• Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC) \*Presumed low-grade gliomas in this protocol are defined as diffusely infiltrated non-contrast enhancing tumors on MRI. Patients with known LGG scheduled for re-surgery or primary surgery after a diagnostic biopsy may also be included.

You may not qualify if:

• Any known allergy or hypersensitivity to indocyanine green (ICG)
• Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
• Pre-existing hepatic and/or renal insufficiency
• INR above 1.7
• Estimated GFR (eGFR) below 45 ml/min/1.73m2
• Unwilling or unable to follow the protocol requirements

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Related Publications (3)

• De Witt Hamer PC, Robles SG, Zwinderman AH, Duffau H, Berger MS. Impact of intraoperative stimulation brain mapping on glioma surgery outcome: a meta-analysis. J Clin Oncol. 2012 Jul 10;30(20):2559-65. doi: 10.1200/JCO.2011.38.4818. Epub 2012 Apr 23.

  PMID: 22529254 BACKGROUND

• Skjoth-Rasmussen J, Azam A, Larsen CC, Scheie D, Juhl K, Kjaer A. A new uPAR-targeting fluorescent probe for optical guided intracranial surgery in resection of a meningioma-a case report. Acta Neurochir (Wien). 2022 Jan;164(1):267-271. doi: 10.1007/s00701-021-05051-3. Epub 2021 Nov 8.

  PMID: 34748074 BACKGROUND

• Skjøth-Rasmussen J, Azam A, Juhl K, Ginsborg S, Kryspin Sørensen M, Sølling C, Larsen CC, Scheie D, Kjaer A. First-in-human study of a novel Upar-targeted imaging agent (FGO01) for visualization of malignant glioma during surgery. Brain and Spine. 2022.

  BACKGROUND

MeSH Terms

Conditions

Meningioma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial

Study Officials

• Jane Skjøth-Rasmussen, MD, PhD

  Department of neurosurgery, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Skjøth-Rasmussen, MD, PhD

CONTACT

+4535451446; jane.skjoeth-rasmussen@regionh.dk

Aleena Azam, MD, PhD student

CONTACT

+4535456208; aleena.azam@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 40 patients are planned for enrolment. The study will include two arms, where one arm will consist of patients with presumed low-grade gliomas (pLGG) and one with meningiomas. Initially, 20 patients (pLGG=10 and meningioma=10) will be enrolled in the trial followed by an interim analysis. Here, further modifications in the trial with respect to dose administration time and administered dose is possible before enrolment of the last 20 patients (pLGG=10 and meningioma=10).

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: November 12, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)