Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases

Glioma, Malignant Clinical Trial

— CONFLUENSE  

Official title:

Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474573
• Other study ID #: 9c
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Sklifosovsky Institute of Emergency Care
• Contact: Alexander Dmitriev, MD
• Phone: +7 (916) 423-54-08
• Email: dmitriev[@]neurosklif.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant
• Metastases to Brain
• Neoplasm Metastasis

Intervention

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
• Fluorescence-guided brain tumor resection
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Locations

Country	Name	City	State
Russian Federation	Sklifosovsky Institute of Emergency Care	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sklifosovsky Institute of Emergency Care

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross total resection (Yes or No)	No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging	within 48 hours after surgery
Secondary	Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	within 48 hours after surgery
Secondary	Motor function (in grades)	Motor function is assessed in Medical Research Council scale	within 10 days after surgery
Secondary	Speech function (in grades)	Speech function is assessed in Hendrix scale (2017)	within 10 days after surgery
Secondary	Karnofsky performance status (in percents)	Assesses patients' possibilities to self-service in Karnofsky Performance Status scale	within 10 days after surgery
Secondary	Cerebral complications	Which cerebral complications arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days