Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined ultrasound and fluorescence-guided brain tumor resection, Fluorescence-guided brain tumor resection.
- Who it may be relevant to
- Registry conditions: Glioma, Malignant, Metastases to Brain. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Overview
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.
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
Primary outcome measures
- Gross total resection (Yes or No) [Time frame: within 48 hours after surgery]
Secondary outcome measures (5)
- Extent of resection (in percents) [Time frame: within 48 hours after surgery]
- Motor function (in grades) [Time frame: within 10 days after surgery]
- Speech function (in grades) [Time frame: within 10 days after surgery]
- Karnofsky performance status (in percents) [Time frame: within 10 days after surgery]
- Cerebral complications [Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Sklifosovsky Institute of Emergency Care — Moscow
Identifiers
NCT: NCT05474573 · 9c