Clinical trial NCT05474573: Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases
Official title: Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma, Malignant
Metastases to Brain
Keywords: contrast-enhancing glioma
brain metastasis
sonography
ultrasound
fluorescence
5-aminolevulinic acid
5-ALA
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-07-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Gross total resection (Yes or No)
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Extent of resection (in percents)
timeFrame: within 48 hours after surgery
measure: Motor function (in grades)
timeFrame: within 10 days after surgery
measure: Speech function (in grades)
timeFrame: within 10 days after surgery
measure: Karnofsky performance status (in percents)
timeFrame: within 10 days after surgery
measure: Cerebral complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References: