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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-08-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Gliomas, Malignant Metastases to Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Ultrasound

Intraoperative extent of tumor resection will be assessed using sonography

Group Type EXPERIMENTAL

Ultrasound guided brain tumor resection

Intervention Type DEVICE

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Fluorescence

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

Group Type ACTIVE_COMPARATOR

5-aminolevulinic acid fluorescence-guided brain tumor resection

Intervention Type DEVICE

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

Interventions

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Ultrasound guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection using ultrasound

Intervention Type DEVICE

5-aminolevulinic acid fluorescence-guided brain tumor resection

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No