NCT05474573

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2022Aug 2027

First Submitted

Initial submission to the registry

July 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

July 23, 2022

Last Update Submit

May 13, 2025

Conditions

Glioma, MalignantMetastases to Brain

Keywords

contrast-enhancing gliomabrain metastasissonographyultrasoundfluorescence5-aminolevulinic acid5-ALA

Outcome Measures

Primary Outcomes (1)

  • Gross total resection (Yes or No)

    No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging

    within 48 hours after surgery

Secondary Outcomes (5)

  • Extent of resection (in percents)

    within 48 hours after surgery

  • Motor function (in grades)

    within 10 days after surgery

  • Speech function (in grades)

    within 10 days after surgery

  • Karnofsky performance status (in percents)

    within 10 days after surgery

  • Cerebral complications

    From admission to intensive care unit after surgery till hospital discharge, up to 365 days

Study Arms (2)

Fluorescence and Ultrasound

EXPERIMENTAL

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

Fluorescence

ACTIVE COMPARATOR

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

Device: Fluorescence-guided brain tumor resection

Interventions

Combined ultrasound and fluorescence-guided brain tumor resectionDEVICE

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

Fluorescence and Ultrasound
Fluorescence-guided brain tumor resectionDEVICE

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

Fluorescence

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

RECRUITING

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alexander Dmitriev, MD

    Sklifosovsky Institute of Emergency Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Dmitriev, MD

CONTACT

+7 (916) 423-54-08dmitriev@neurosklif.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon, MD

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 26, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)