Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Neoplasm Metastasis

Glioma

Brain Neoplasms

Neoplastic Processes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Intraoperative extent of tumor resection will be assessed using sonography

Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Ultrasound guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

5-aminolevulinic acid fluorescence-guided brain tumor resection

Alexander Dmitriev, MD

Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection.

Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery.

Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists

Tumor extent of resection will be assessed by radiologists blinded for the treatment arm

Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases

Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial

No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Motor function is assessed in Medical Research Council scale

Speech function is assessed in Hendrix scale (2017)

Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

Which cerebral complications arose after surgery

Sklifosovsky Institute of Emergency Care

Principal Investigator

Recurrence

Glioblastoma

Astrocytoma

Oligodendroglioma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Antineoplastic Agents

Anti-Infective Agents

Fluorouracil

Flucytosine

Clotrimazole

Miconazole

Antifungal Agents

Antimetabolites

Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector

Toca 511 vector

Toca FC is an extended-release formulation of flucytosine.

Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine

Asha Das, MD

Michael Vogelbaum, MD, PhD, NS

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care.

If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients.

Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals.

After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years.

All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.

A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

This will be based on treatment emergent adverse events, clinical laboratory values and viral testing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases	NCT05475522	Gliomas, Malign... Metastases to B...	Ultrasound guid... 5-aminolevulini...	18 Years - 79 Years	Sklifosovsky Institute of Emergency Care
A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511	NCT04327011	Glioblastoma Mu... Astrocytoma Gliomas, Malign...	Toca 511 vector Toca FC • Flucy...	18 Years -	Tocagen Inc.

Spots Global Cancer Trial Database for gliomas, malignant