Sklifosovsky Institute of Emergency Care
Moscow, 129090, Russia
Location status: Recruiting
NCT Number: NCT05474573
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.
Interested in participating?
Request Info18 year–79 year
All sexes
Interventional
Not applicable
Moscow, 129090, Russia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Time frame: within 48 hours after surgery
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Time frame: within 48 hours after surgery
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time frame: within 10 days after surgery
Motor function is assessed in Medical Research Council scale
Time frame: within 10 days after surgery
Speech function is assessed in Hendrix scale (2017)
Time frame: within 10 days after surgery
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Which cerebral complications arose after surgery
Contact information is provided by the study sponsor or research team.
Sklifosovsky Institute of Emergency Care
Other Gov
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Acronym: CONFLUENSE
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