Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases

Study Purpose

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

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 from any cancer.

- 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.	NCT05474573
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.	Glioma, Malignant, Metastases to Brain

Additional Details

Fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. But the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing to reveal such tumor remnants. By the time there are published results of randomized control trials comparing these two technics. Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone. Participants of the study will be randomly operated using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. Extent of resection will be assessed in postoperative MRI by blinded radiologists.

Arms & Interventions

Arms

Experimental: Fluorescence and Ultrasound

Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography

Active Comparator: Fluorescence

Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid

Interventions

Device: - Combined ultrasound and fluorescence-guided brain tumor resection

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

Device: - Fluorescence-guided brain tumor resection

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

Contact a Trial Team

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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

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