Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2-ICG
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTiffany Hodges
About this trial
Participants in this research study are people who are likely to have, or have been diagnosed with a brain tumor, for which surgical removal (or "resection") is the standard of care treatment. The purpose of this study is to see whether a drug called SBK2-ICG can be used to locate the true outline or "edges" of the tumor. If the tumor outline could be accurately identified at the time of surgery, the fullest extent of tumor could be removed while sparing the normal brain tissue.
Participants will receive SBK2-ICG about an hour before they receive surgery. The extent of surgery to be performed will not be changed in this study. Researchers will only use the information from the study to determine the best SBK2-ICG dose for accurate tumor margin (i.e., the border or edges of the tumor with the normal brain) detection so that no tumor is left behind.
The use of SBK2-ICG in brain tumors is experimental, which means that the U.S. Food and Drug Administration (FDA) has not approved it for use to locate brain tumors. However, the use of the drug SBK2-ICG for the purposes of this study is on file with the FDA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have suspected or confirmed untreated malignant brain tumors
Participants must have received no prior therapies for this disease.
Participants are 18 years of age or older. Because no dosing or adverse event data are currently available on the use of SBK2-ICG in individuals under 18 years of age, children are excluded from this study.
Karnofsky Performance status ≥ 60%
Disqualifiers
Pregnant individuals or those who are breast feeding.
Individuals with AST, ALT, ALP, or bilirubin >2.5x normal upper limit any time during the previous 2 months.
Individuals with plasma creatinine > 2.5 mg/dL.
Individuals without a probable or expected grade IV glioma.
Trial design
Design model
Single group
Treatments tested in this trial
SBK2-ICG
DrugParticipants will receive a single intravenous (IV) dose of SBK2-ICG one hour prior to their craniotomy (brain surgery). The starting dose is 0.072 mg/kg. The dose may be adjusted based on participants experiencing adverse events or based on participant response and fluorescence detection. If the 0.072mg/kg dose is well tolerated, researchers will examine fluorescence. If there are no Grade II or higher adverse events and researchers observe good fluorescence that is specific, researchers will continue to use that dose. If there is no fluorescence and the dose is well tolerated, researchers will increase the dose 0.216mg/kg. If there is too much background fluorescence, researchers can drop to a lower dose (0.072 mg/kg or 0.024 mg/kg).
Craniotomy (Standard of Care)
Procedure/SurgeryParticipants will undergo a craniotomy (brain surgery) per standard of care. During the surgery, the study drug SBK2-ICG (given one hour prior to the surgery) and fluorescence light will be used to visualize the brain tumor(s). White light images (the standard of care) will also be used to visualize the tumor(s). The surgeon will take tissue biopsies based on standard of care processes.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: SBK2-ICG-Guided Fluorescence Imaging of Brain TumorsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)
Safety will be measured by prevalence of AEs, defined according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 criteria.
Time frame
Up to 14 days after surgery (Day 14)Secondary outcomes
1
Diagnostic performance of the imaging agent SBK2-ICG relative to 5-ALA
Diagnostic performance will be measured on the basis of a visual score of the imaging agent's ability to detect high-grade invasive glioma tumor in comparison to histopathological samples and/or standard white light from surgical microscope at the variable dose levels.
Time frame
Day of surgery (Day 1)2
Clinical usefulness of the imaging agent SBK2-ICG for eventual fluorescence-guided resection, as measured by percent tumor present
The tumor present in the biopsy specimens will be compared to the percentage of tumor identified via the imaging agent SBK2-ICG at the dose levels tested.
Time frame
Day of surgery (Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tiffany Hodges
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov
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