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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 79 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) - one or several brain metastases.

- newly diagnosed.

- Karnofsky Performance Status 60-100% - age 18-79 years.

- performed magnetic resonance imaging with contrast enhancement.

Exclusion Criteria:

- tumor spreading to corpus callosum or brainstem.

- previously performed brain radiotherapy.

- planned supratotal tumor resection until neurophysiologically revealed eloquent areas.

- known hypersensibility to 5-aminolevulinic or to porphyrin.

- hepatic or renal insufficiency.

- porphyria.

- pregnancy.

- breast feeding

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05475522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sklifosovsky Institute of Emergency Care
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexander Dmitriev, MD
Principal Investigator Affiliation	Sklifosovsky Institute of Emergency Care
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gliomas, Malignant, Metastases to Brain

Additional Details

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

Arms & Interventions

Arms

Experimental: Ultrasound

Intraoperative extent of tumor resection will be assessed using sonography

Active Comparator: Fluorescence

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

Interventions

Device: - Ultrasound guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Device: - 5-aminolevulinic acid fluorescence-guided brain tumor resection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sklifosovsky Institute of Emergency Care, Moscow, Russian Federation

Status

Recruiting

Address

Sklifosovsky Institute of Emergency Care

Moscow, , 129090

Site Contact

Alexander Dmitriev, MD

[email protected]

+7 (916) 423-54-08

Clinical Trial Finder