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

Sponsor

Sklifosovsky Institute of Emergency Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05474573

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma, Malignant Metastases to Brain	Device: Combined ultrasound and fluorescence-guided brain tumor resection Device: Fluorescence-guided brain tumor resection	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Tumor extent of resection will be assessed by radiologists blinded for the treatment arm

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluorescence and Ultrasound Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography	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
Active Comparator: Fluorescence Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid	Device: Fluorescence-guided brain tumor resection Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Arm

Intervention/Treatment

Experimental: Fluorescence and Ultrasound

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

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

Active Comparator: Fluorescence

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

Device: Fluorescence-guided brain tumor resection

Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope

Outcome Measures

Primary Outcome Measures

Gross total resection (Yes or No) [within 48 hours after surgery]
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

Secondary Outcome Measures

Extent of resection (in percents) [within 48 hours after surgery]
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Motor function after surgery (in scores) [within 10 days after surgery]
Motor function is measured in Medical Research Council scale
Speech after surgery (in scores) [within 10 days after surgery]
Speech function is measured in Bilingual Aphasia Screening Test (Russian version)
Visual field loss after surgery [within 10 days after surgery]
Visual field loss is measured as area of visual defect in perimetry
Cognitive disturbances after surgery (in scores) [within 10 days after surgery]
Cognitive disturbances are measured in Montreal Cognitive Assessment scale
Karnofsky performance status (in percents) [within 10 days after surgery]
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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 basal ganglia, 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