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

Primary Purpose

Glioma, Malignant, Metastases to Brain

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Combined ultrasound and fluorescence-guided brain tumor resection
Fluorescence-guided brain tumor resection
Sponsored by
Sklifosovsky Institute of Emergency Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma, Malignant focused on measuring contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sklifosovsky Institute of Emergency CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluorescence and Ultrasound

Fluorescence

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gross total resection (Yes or No)
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

Secondary Outcome Measures

Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Cerebral complications
Which cerebral complications arose after surgery

Full Information

First Posted
July 23, 2022
Last Updated
December 12, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
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1. Study Identification

Unique Protocol Identification Number
NCT05474573
Brief Title
Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases
Acronym
CONFLUENSE
Official Title
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Malignant, Metastases to Brain
Keywords
contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorescence and Ultrasound
Arm Type
Experimental
Arm Description
Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography
Arm Title
Fluorescence
Arm Type
Active Comparator
Arm Description
Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid
Intervention Type
Device
Intervention Name(s)
Combined ultrasound and fluorescence-guided brain tumor resection
Intervention Description
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography
Intervention Type
Device
Intervention Name(s)
Fluorescence-guided brain tumor resection
Intervention Description
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
Primary Outcome Measure Information:
Title
Gross total resection (Yes or No)
Description
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Time Frame
within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Extent of resection (in percents)
Description
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time Frame
within 48 hours after surgery
Title
Motor function (in grades)
Description
Motor function is assessed in Medical Research Council scale
Time Frame
within 10 days after surgery
Title
Speech function (in grades)
Description
Speech function is assessed in Hendrix scale (2017)
Time Frame
within 10 days after surgery
Title
Karnofsky performance status (in percents)
Description
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Time Frame
within 10 days after surgery
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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