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

Sklifosovsky Institute of Emergency Care

Status: Enrolling

Conditions: Metastases to Brain; Glioma, Malignant

Treatments: Device: Fluorescence-guided brain tumor resection; Device: Combined ultrasound and fluorescence-guided brain tumor resection

Study type: Interventional

Funder types: Other

Identifiers

NCT05474573

9c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Fluorescence and Ultrasound

Experimental group

Description:

Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography

Treatment:

Device: Combined ultrasound and fluorescence-guided brain tumor resection

Fluorescence

Active Comparator group

Description:

Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid

Treatment:

Device: Fluorescence-guided brain tumor resection