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

November 9, 2024 updated by: Jane Skjøth-Rasmussen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The drug FG001 (ICG-Glu-Glu-AE105), a uPAR-targeting fluorescent drug, has been tested in patients with high-grade glioma as part of a First-in-human clinical trial and demonstrated an excellent safety profile and efficacy results. Animal studies have indicated uptake of FG001 in low-grade glioma while uptake has been shown in one clinical case of meningioma providing the basis for this trial.

Consequently, the investigators intend to test the ability of FG001 to reliably fluoresce in patients with presumed low-grade glioma or meningioma.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects will be entered into this trial only if they meet all the following criteria:

  1. Subjects diagnosed with primary brain tumor on MRI suggestive of, 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) *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.

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 above 1.7
    • Estimated GFR (eGFR) below 45 ml/min/1.73m2
  5. Unwilling or unable to follow the protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Presumed low-grade glioma
Drug: FG001 prior to surgery
Patients will receive a single intravenous injection of 36 mg FG001 administered the day before surgery.
Experimental: Meningioma
Drug: FG001 prior to surgery
Patients will receive a single intravenous injection of 36 mg FG001 administered the day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary objective
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: 24 months
The efficacy of FG001 as a tumor imaging agent and safety will be monitored. The efficacy is examined by the sensitivity and specificity. Sensitivity is defined as the probability that a test result is positive when the subject has the disease, while specificity is the probability that a test result is negative when the patient does not have the disease. Safety is determined by physical examinations, laboratory samples and the incidence and severity of the Adverse events (AEs), which are evaluated by National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Jane Skjøth-Rasmussen, MD, PhD, Department of neurosurgery, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

November 9, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-FG001-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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