Gliomas, MalignantSONOFLUONCT05475522
Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases
A study testing Ultrasound guided brain tumor resection and 5-aminolevulinic acid fluorescence-guided brain tumor resection in people with Gliomas, Malignant and Metastases to Brain, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial summary
Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Gliomas, Malignant, Metastases to Brain
- What is being tested?
- Ultrasound guided brain tumor resection and 5-aminolevulinic acid fluorescence-guided brain tumor resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
- one or several brain metastases
- newly diagnosed
- Karnofsky Performance Status 60-100%
- age 18-79 years
- performed magnetic resonance imaging with contrast enhancement
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial
Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid
Read the detailed description
Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection.
Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery.
Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists
- Conditions
- Gliomas, Malignant, Metastases to Brain
- Being tested
- Ultrasound guided brain tumor resection, 5-aminolevulinic acid fluorescence-guided brain tumor resection
- Keywords
- contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA
- 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.
Ultrasound guided brain tumor resectionDevice
Surgeon intraoperatively assesses extent of tumor resection using ultrasound
5-aminolevulinic acid fluorescence-guided brain tumor resectionDevice
Surgeon intraoperatively assesses extent of tumor resection observing it's fluorescence in microscope
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Intraoperative extent of tumor resection will be assessed using sonography Receives: Device: Ultrasound guided brain tumor resection |
| Fluorescence | Active comparator | Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid Receives: Device: 5-aminolevulinic acid 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 posted27 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Why it stopped: technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gliomas, 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
- 134 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
- NCT05475522
- Sponsor's protocol ID
- 9b
- Acronym
- SONOFLUO
- Status last verified
- May 2025
- First submitted
- 22 Jul 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT05475522
- Acronym / sponsor ID
- SONOFLUO / 9b
- Conditions
- Gliomas, Malignant, Metastases to Brain
- Keywords
- contrast-enhancing glioma, brain metastasis, sonography, ultrasound, fluorescence, 5-aminolevulinic acid, 5-ALA
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: technical issues
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 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.
Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid
Detailed description
Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection.
Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery.
Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Ultrasound guided brain tumor resectionIntraoperative extent of tumor resection will be assessed using sonography |
| Fluorescence | Active comparator | Device: 5-aminolevulinic acid fluorescence-guided brain tumor resectionIntraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
- one or several brain metastases
- newly diagnosed
- Karnofsky Performance Status 60-100%
- age 18-79 years
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Ultrasound guided brain tumor resectionSurgeon intraoperatively assesses extent of tumor resection using ultrasound | Device | Ultrasound |
| 5-aminolevulinic acid 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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. This study is not recruiting at the moment.
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 Ultrasound guided brain tumor resection and 5-aminolevulinic acid fluorescence-guided brain tumor resection in people with Gliomas, 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 6 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: paused, as of the sponsor's last update on 16 May 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 May 2025.