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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorSklifosovsky Institute of Emergency Care

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Fluorescence and UltrasoundExperimental treatment 1 intervention
Group B: FluorescenceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gross total resection (Yes or No)

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

Time frame
within 48 hours after surgery

Secondary outcomes

1

Extent of resection (in percents)

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

Time frame
within 48 hours after surgery
2

Motor function (in grades)

Motor function is assessed in Medical Research Council scale

Time frame
within 10 days after surgery
3

Speech function (in grades)

Speech function is assessed in Hendrix scale (2017)

Time frame
within 10 days after surgery
4

Karnofsky performance status (in percents)

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

Time frame
within 10 days after surgery

Other outcomes

Sponsors and contacts

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