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

S

Sklifosovsky Institute of Emergency Care

Status

Enrolling

Conditions

Gliomas, Malignant
Metastases to Brain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full description

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

Enrollment

134 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

134 participants in 2 patient groups

Ultrasound
Experimental group
Description:
Intraoperative extent of tumor resection will be assessed using sonography
Treatment:
Device: Ultrasound guided brain tumor resection
Fluorescence
Active Comparator group
Description:
Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid
Treatment:
Device: 5-aminolevulinic acid fluorescence-guided brain tumor resection

Trial contacts and locations

1

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Central trial contact

Alexander Dmitriev, MD

Data sourced from clinicaltrials.gov

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