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NCT Number: NCT05474573

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

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.

Recruiting

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Combined ultrasound and fluorescence-guided brain tumor resection

Device

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

Fluorescence-guided brain tumor resection

Device

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

Primary outcomes

  1. Gross total resection (Yes or No)

    Time frame: within 48 hours after surgery

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

Secondary outcomes

  1. Extent of resection (in percents)

    Time frame: within 48 hours after surgery

    Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

  2. Motor function (in grades)

    Time frame: within 10 days after surgery

    Motor function is assessed in Medical Research Council scale

  3. Speech function (in grades)

    Time frame: within 10 days after surgery

    Speech function is assessed in Hendrix scale (2017)

  4. Karnofsky performance status (in percents)

    Time frame: within 10 days after surgery

    Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

  5. Cerebral complications

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

    Which cerebral complications arose after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Dmitriev, MD

CONTACT

[email protected]

+7 (916) 423-54-08

Sponsors and collaborators

Lead sponsor

Sklifosovsky Institute of Emergency Care

Other Gov

Registry information

Official study title

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

Acronym: CONFLUENSE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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