Glioma, MalignantCONFLUENCENCT05474573
Concurrent Fluorescence and Sonographically Guided Eradication of High-grade Gliomas and Metastases
A study testing Combined ultrasound and fluorescence-guided brain tumor resection and Fluorescence-guided brain tumor resection in people with Glioma, Malignant and Metastases to Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial summary
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma, Malignant, Metastases to Brain
- What is being tested?
- Combined ultrasound and fluorescence-guided brain tumor resection and Fluorescence-guided brain tumor resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single high-grade glioma
- solitary, single or multiple brain metastases of solid tumors of any primary origin
- newly diagnosed
- Karnofsky Performance Status 60-100%
- age 18-80 years
- performed magnetic resonance imaging with contrast enhancement
- intraoperative use of 5-aminolevulinic acid induced fluorescence.
Who cannot join
- tumor spreading to corpus callosum or brainstem
- history of brain tumor 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Sklifosovsky Institute of Emergency Care
Moscow, 129090
Alexander Dmitriev, MD, +7 (916) 423-54-08, dmitriev@neurosklif.ru
About this study
Official title: Concurrent Fluorescence and Sonographically Guided Eradication of High-grade Gliomas and Metastases: a Randomised, Controlled Trial
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Read the detailed description
Fluorescence-guided resection of high-grade gliomas and brain metastases increases the extent of tumor resection. However, the main drawback of this method is the inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing for the detection of such tumor remnants. To date, there are no published results of randomized controlled trials comparing these two techniques.
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Participants in the study will be randomly assigned to undergo surgery using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. The extent of resection will be assessed via postoperative MRI by blinded radiologists and neurosurgeons independently.
- Conditions
- Glioma, Malignant, Metastases to Brain
- Being tested
- Combined ultrasound and fluorescence-guided brain tumor resection, Fluorescence-guided brain tumor resection
- Keywords
- brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA, high-grade glioma
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-guided brain tumor resectionDevice
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence and Ultrasound | Experimental | Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography Receives: 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 Receives: Device: Fluorescence-guided brain tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross total resection (Yes or No)
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
Measured: within 48 hours after surgery
Secondary outcomes (5)
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Measured: within 48 hours after surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Measured: within 10 days after surgery
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Measured: within 10 days after surgery
Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Measured: within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Measured: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Dmitriev, Sklifosovsky Institute of Emergency Care
- Investigators
- Alexander Dmitriev, MD, Principal investigator, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474573
- Sponsor's protocol ID
- 9c
- Acronym
- CONFLUENCE
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Fluorescence and Sonographically Guided Eradication of High-grade Gliomas and Metastases: a Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT05474573
- Acronym / sponsor ID
- CONFLUENCE / 9c
- Conditions
- Glioma, Malignant, Metastases to Brain
- Keywords
- brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA, high-grade glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Detailed description
Fluorescence-guided resection of high-grade gliomas and brain metastases increases the extent of tumor resection. However, the main drawback of this method is the inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing for the detection of such tumor remnants. To date, there are no published results of randomized controlled trials comparing these two techniques.
The objective of the study is to determine whether the combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve a higher rate of gross total resection in hemispheric high-grade gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Participants in the study will be randomly assigned to undergo surgery using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. The extent of resection will be assessed via postoperative MRI by blinded radiologists and neurosurgeons independently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence and Ultrasound | Experimental | Device: Combined ultrasound and fluorescence-guided brain tumor resectionExtent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography |
| Fluorescence | Active comparator | Device: Fluorescence-guided brain tumor resectionExtent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- single high-grade glioma
- solitary, single or multiple brain metastases of solid tumors of any primary origin
- newly diagnosed
- Karnofsky Performance Status 60-100%
- age 18-80 years
Key exclusion criteria (8 listed)
- tumor spreading to corpus callosum or brainstem
- history of brain tumor radiotherapy
- planned supratotal tumor resection (until neurophysiologically revealed eloquent areas)
- known hypersensibility to 5-aminolevulinic or to porphyrin
- hepatic or renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined ultrasound and fluorescence-guided brain tumor resectionSurgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope and performing sonography | Device | Fluorescence and Ultrasound |
| Fluorescence-guided brain tumor resectionSurgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope | Device | Fluorescence |
Primary outcome
Gross total resection (Yes or No)
Time frame: within 48 hours after surgery
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
5 secondary outcomes
Extent of resection (in percents)
Time frame: within 48 hours after surgery
Motor function (in grades)
Time frame: within 10 days after surgery
Speech function (in grades)
Time frame: within 10 days after surgery
Karnofsky performance status (in percents)
Time frame: within 10 days after surgery
Cerebral complications
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Dmitriev, MD principal investigator
Sklifosovsky Institute of Emergency Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined ultrasound and fluorescence-guided brain tumor resection and Fluorescence-guided brain tumor resection in people with Glioma, Malignant and Metastases to Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Dmitriev, MD (+7 (916) 423-54-08, dmitriev@neurosklif.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross total resection (Yes or No) (time frame: within 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.