Malignant Brain TumorsPhase 1NCT07438860
Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2-ICG
A Phase 1 study testing SBK2-ICG in people with Malignant Brain Tumors and Glioma, run by Tiffany Hodges at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Tumors, Glioma
- What is being tested?
- SBK2-ICG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2026to 31 Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
- Glioma is located in the supratentorial region of the brain.
- Tumor is suitable for resection on the basis of imaging studies and participant and surgeon must plan resection
- Able and willing to undergo MRI scan.
- Participants must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- 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.
- Individuals not planning surgery on glioma.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG or other agents used in this study.
- Note: A baseline blood sample will be drawn for creatinine, AST, ALT, ALP, and bilirubin to verify whether or not this exclusion criterion is met.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Tiffany Hodges, MD
Tiffany Hodges, MD
Premier Health Neuroscience Institute
Dayton, Ohio, 45409
Andrew Sloan, MD, FACS
Andrew Sloan, MD, FACS
About this study
Official title: Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2- ICG in a Phase 1 Clinical 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.
Read the detailed description
Treating people with serious brain tumors is challenging, and the outlook for these people is poor. On average, people survive less than one year after their are diagnosed. How long someone lives after diagnosis and treatment may depend on how much of the tumor is able to be removed with surgery. However, it can be difficult for surgeons to tell the difference between where the tumor is and where healthy brain tissue is using standard white light surgical microscope illumination. Because of this, new methods to help surgeons see tumor borders more clearly during surgery could be valuable.
Fluorescence imaging may be one method that can help surgeons see tumor borders more clearly. Previous studies have used fluorescence imaging to better visualize tumors, but no previous studies have used SBK2-ICG. In fact, the use of SBK2-ICG is conceptually different than other studies.
Currently, the only FDA approved drug used in fluorescent imaging for visualizing brain tumors during surgery is called 5-aminolevulinic acid, or 5-ALA. 5-ALA is naturally metabolized in human cells to something called PpIX. When people are given 5-ALA before surgery, it gets turned into PpIX, which can then be excited by fluorescent light at wavelengths of 400-410 nm. Because tumor cells and healthy cells metabolize 5-ALA in different ways, PpIX tends to accumulate in epithelial and malignant cells, including brain tumor cells. In a review of previous studies, using 5-ALA was associated with better removal of tumor tissue, longer overall survival, and longer progression-free survival. However, 5-ALA only weakly detects tumor borders and does not identify infiltrative cells on the edges of tumors. Also, even thin barriers of normal cells can make it difficult for surgeons to see 5-ALA, which makes it difficult to tell the difference between tumor tissue and healthy tissue. Because of this, it would be helpful to use a drug that emits a light that more deeply penetrates brain tissue so that surgeons can see tumor tissue and healthy tissue better.
SBK2-ICG is different than 5-ALA because it is not metabolized by the human body. Instead, SBK2-ICG attaches to a unique piece of cells that accumulates in tumors. SBK2-ICG can also be excited at a wavelength of 789 nm, rather than the wavelength of 400-410 nm that 5-ALA is excited at. SBK2-ICG gives off a near infrared light when it is excited, making it easier to see the borders of tumors. It also helps with seeing deep inside of the tumor. Using SBK2-ICG and fluorescent light has been shown to identify more than 99% of tumor cells in rodent xenograft models of human brain tumors in the lab.
Researchers want to assess the safety of SBK2-ICG in people with brain tumors who are already planning to have surgery to remove their tumor and see how SBK2-ICG compares to standard practices in identifying tumor tissue versus healthy tissue.
- Conditions
- Malignant Brain Tumors, Glioma
- Being tested
- SBK2-ICG, Craniotomy (Standard of Care)
- Keywords
- SBK2-ICG
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBK2-ICGDrug
Participants 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 or surgery
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors | Experimental | Participants will receive study drug SBK2-ICG one hour prior to their standard of care craniotomy (brain surgery), where fluorescence images will be take in addition to white light (standard of care) images. Receives: Drug: SBK2-ICG; Procedure: Craniotomy (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days after surgery (Day 14)
Secondary outcomes (2)
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.
Measured: Day of surgery (Day 1)
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.
Measured: Day of surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Malignant Brain TumorsStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiffany Hodges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tiffany Hodges, Case Comprehensive Cancer Center
- Investigators
- Tiffany Hodges, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438860
- Sponsor's protocol ID
- CASE8325
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostrom QT, Price M, Neff C, Cioffi G, Waite KA, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022 Oct 5;24(Suppl 5):v1-v95. doi: 10.1093/neuonc/noac202.
PubMed 36196752Chaichana KL, Parker SL, Mukherjee D, Cheng JS, Gokaslan ZL, McGirt MJ. Assessment of the extent of surgical resection as a predictor of survival in patients with primary osseous spinal neoplasms. Clin Neurosurg. 2011;58:117-21. doi: 10.1227/neu.0b013e318226fff7. No abstract available.
PubMed 21916135Keereweer S, Kerrebijn JD, van Driel PB, Xie B, Kaijzel EL, Snoeks TJ, Que I, Hutteman M, van der Vorst JR, Mieog JS, Vahrmeijer AL, van de Velde CJ, Baatenburg de Jong RJ, Lowik CW. Optical image-guided surgery--where do we stand? Mol Imaging Biol. 2011 Apr;13(2):199-207. doi: 10.1007/s11307-010-0373-2.
PubMed 20617389Gao X, Cui Y, Levenson RM, Chung LW, Nie S. In vivo cancer targeting and imaging with semiconductor quantum dots. Nat Biotechnol. 2004 Aug;22(8):969-76. doi: 10.1038/nbt994. Epub 2004 Jul 18.
PubMed 15258594Richards-Kortum R, Sevick-Muraca E. Quantitative optical spectroscopy for tissue diagnosis. Annu Rev Phys Chem. 1996;47:555-606. doi: 10.1146/annurev.physchem.47.1.555.
PubMed 8930102Stummer W, Reulen HJ, Meinel T, Pichlmeier U, Schumacher W, Tonn JC, Rohde V, Oppel F, Turowski B, Woiciechowsky C, Franz K, Pietsch T; ALA-Glioma Study Group. Extent of resection and survival in glioblastoma multiforme: identification of and adjustment for bias. Neurosurgery. 2008 Mar;62(3):564-76; discussion 564-76. doi: 10.1227/01.neu.0000317304.31579.17.
PubMed 18425006Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
PubMed 16648043Marshall MV, Draney D, Sevick-Muraca EM, Olive DM. Single-dose intravenous toxicity study of IRDye 800CW in Sprague-Dawley rats. Mol Imaging Biol. 2010 Dec;12(6):583-94. doi: 10.1007/s11307-010-0317-x.
PubMed 20376568Tonn JC, Stummer W. Fluorescence-guided resection of malignant gliomas using 5-aminolevulinic acid: practical use, risks, and pitfalls. Clin Neurosurg. 2008;55:20-6. No abstract available.
PubMed 19248665Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1.
PubMed 34624862Eatz TA, Eichberg DG, Lu VM, Di L, Komotar RJ, Ivan ME. Intraoperative 5-ALA fluorescence-guided resection of high-grade glioma leads to greater extent of resection with better outcomes: a systematic review. J Neurooncol. 2022 Jan;156(2):233-256. doi: 10.1007/s11060-021-03901-9. Epub 2022 Jan 6.
PubMed 34989964Burgoyne AM, Phillips-Mason PJ, Burden-Gulley SM, Robinson S, Sloan AE, Miller RH, Brady-Kalnay SM. Proteolytic cleavage of protein tyrosine phosphatase mu regulates glioblastoma cell migration. Cancer Res. 2009 Sep 1;69(17):6960-8. doi: 10.1158/0008-5472.CAN-09-0863. Epub 2009 Aug 18.
PubMed 19690139Burgoyne AM, Palomo JM, Phillips-Mason PJ, Burden-Gulley SM, Major DL, Zaremba A, Robinson S, Sloan AE, Vogelbaum MA, Miller RH, Brady-Kalnay SM. PTPmu suppresses glioma cell migration and dispersal. Neuro Oncol. 2009 Dec;11(6):767-78. doi: 10.1215/15228517-2009-019.
PubMed 19304959Burden-Gulley SM, Qutaish MQ, Sullivant KE, Tan M, Craig SE, Basilion JP, Lu ZR, Wilson DL, Brady-Kalnay SM. Single cell molecular recognition of migrating and invading tumor cells using a targeted fluorescent probe to receptor PTPmu. Int J Cancer. 2013 Apr 1;132(7):1624-32. doi: 10.1002/ijc.27838. Epub 2012 Oct 11.
PubMed 22987116
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2- ICG in a Phase 1 Clinical Trial
- ClinicalTrials.gov ID
- NCT07438860
- Acronym / sponsor ID
- CASE8325
- Conditions
- Malignant Brain Tumors, Glioma
- Keywords
- SBK2-ICG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tiffany HodgesUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
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.
Detailed description
Treating people with serious brain tumors is challenging, and the outlook for these people is poor. On average, people survive less than one year after their are diagnosed. How long someone lives after diagnosis and treatment may depend on how much of the tumor is able to be removed with surgery. However, it can be difficult for surgeons to tell the difference between where the tumor is and where healthy brain tissue is using standard white light surgical microscope illumination. Because of this, new methods to help surgeons see tumor borders more clearly during surgery could be valuable.
Fluorescence imaging may be one method that can help surgeons see tumor borders more clearly. Previous studies have used fluorescence imaging to better visualize tumors, but no previous studies have used SBK2-ICG. In fact, the use of SBK2-ICG is conceptually different than other studies.
Currently, the only FDA approved drug used in fluorescent imaging for visualizing brain tumors during surgery is called 5-aminolevulinic acid, or 5-ALA. 5-ALA is naturally metabolized in human cells to something called PpIX. When people are given 5-ALA before surgery, it gets turned into PpIX, which can then be excited by fluorescent light at wavelengths of 400-410 nm. Because tumor cells and healthy cells metabolize 5-ALA in different ways, PpIX tends to accumulate in epithelial and malignant cells, including brain tumor cells. In a review of previous studies, using 5-ALA was associated with better removal of tumor tissue, longer overall survival, and longer progression-free survival. However, 5-ALA only weakly detects tumor borders and does not identify infiltrative cells on the edges of tumors. Also, even thin barriers of normal cells can make it difficult for surgeons to see 5-ALA, which makes it difficult to tell the difference between tumor tissue and healthy tissue. Because of this, it would be helpful to use a drug that emits a light that more deeply penetrates brain tissue so that surgeons can see tumor tissue and healthy tissue better.
SBK2-ICG is different than 5-ALA because it is not metabolized by the human body. Instead, SBK2-ICG attaches to a unique piece of cells that accumulates in tumors. SBK2-ICG can also be excited at a wavelength of 789 nm, rather than the wavelength of 400-410 nm that 5-ALA is excited at. SBK2-ICG gives off a near infrared light when it is excited, making it easier to see the borders of tumors. It also helps with seeing deep inside of the tumor. Using SBK2-ICG and fluorescent light has been shown to identify more than 99% of tumor cells in rodent xenograft models of human brain tumors in the lab.
Researchers want to assess the safety of SBK2-ICG in people with brain tumors who are already planning to have surgery to remove their tumor and see how SBK2-ICG compares to standard practices in identifying tumor tissue versus healthy tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors | Experimental | Drug: SBK2-ICG, Procedure: Craniotomy (Standard of Care)Participants will receive study drug SBK2-ICG one hour prior to their standard of care craniotomy (brain surgery), where fluorescence images will be take in addition to white light (standard of care) images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
- Glioma is located in the supratentorial region of the brain.
Key exclusion criteria (7 listed)
- 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.
- Individuals not planning surgery on glioma.
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 |
|---|---|---|
| SBK2-ICGParticipants 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). | Drug | SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors |
| Craniotomy (Standard of Care)Participants 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. | Procedure or surgery | SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors |
Primary outcome
Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)
Time frame: Up to 14 days after surgery (Day 14)
Safety will be measured by prevalence of AEs, defined according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 criteria.
2 secondary outcomes
Diagnostic performance of the imaging agent SBK2-ICG relative to 5-ALA
Time frame: Day of surgery (Day 1)
Clinical usefulness of the imaging agent SBK2-ICG for eventual fluorescence-guided resection, as measured by percent tumor present
Time frame: Day of surgery (Day 1)
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 6 Oct 2026.
- Background: PubMed 36196752Ostrom QT, Price M, Neff C, Cioffi G, Waite KA, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022 Oct 5;24(Suppl 5):v1-v95. doi: 10.1093/neuonc/noac202.
- Background: PubMed 21916135Chaichana KL, Parker SL, Mukherjee D, Cheng JS, Gokaslan ZL, McGirt MJ. Assessment of the extent of surgical resection as a predictor of survival in patients with primary osseous spinal neoplasms. Clin Neurosurg. 2011;58:117-21. doi: 10.1227/neu.0b013e318226fff7. No abstract available.
- Background: PubMed 20617389Keereweer S, Kerrebijn JD, van Driel PB, Xie B, Kaijzel EL, Snoeks TJ, Que I, Hutteman M, van der Vorst JR, Mieog JS, Vahrmeijer AL, van de Velde CJ, Baatenburg de Jong RJ, Lowik CW. Optical image-guided surgery--where do we stand? Mol Imaging Biol. 2011 Apr;13(2):199-207. doi: 10.1007/s11307-010-0373-2.
- Background: PubMed 15258594Gao X, Cui Y, Levenson RM, Chung LW, Nie S. In vivo cancer targeting and imaging with semiconductor quantum dots. Nat Biotechnol. 2004 Aug;22(8):969-76. doi: 10.1038/nbt994. Epub 2004 Jul 18.
- Background: PubMed 8930102Richards-Kortum R, Sevick-Muraca E. Quantitative optical spectroscopy for tissue diagnosis. Annu Rev Phys Chem. 1996;47:555-606. doi: 10.1146/annurev.physchem.47.1.555.
- Background: PubMed 18425006Stummer W, Reulen HJ, Meinel T, Pichlmeier U, Schumacher W, Tonn JC, Rohde V, Oppel F, Turowski B, Woiciechowsky C, Franz K, Pietsch T; ALA-Glioma Study Group. Extent of resection and survival in glioblastoma multiforme: identification of and adjustment for bias. Neurosurgery. 2008 Mar;62(3):564-76; discussion 564-76. doi: 10.1227/01.neu.0000317304.31579.17.
- Background: PubMed 16648043Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
- Background: PubMed 20376568Marshall MV, Draney D, Sevick-Muraca EM, Olive DM. Single-dose intravenous toxicity study of IRDye 800CW in Sprague-Dawley rats. Mol Imaging Biol. 2010 Dec;12(6):583-94. doi: 10.1007/s11307-010-0317-x.
- Background: PubMed 19248665Tonn JC, Stummer W. Fluorescence-guided resection of malignant gliomas using 5-aminolevulinic acid: practical use, risks, and pitfalls. Clin Neurosurg. 2008;55:20-6. No abstract available.
- Background: PubMed 34624862Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1.
- Background: PubMed 34989964Eatz TA, Eichberg DG, Lu VM, Di L, Komotar RJ, Ivan ME. Intraoperative 5-ALA fluorescence-guided resection of high-grade glioma leads to greater extent of resection with better outcomes: a systematic review. J Neurooncol. 2022 Jan;156(2):233-256. doi: 10.1007/s11060-021-03901-9. Epub 2022 Jan 6.
- Background: PubMed 19690139Burgoyne AM, Phillips-Mason PJ, Burden-Gulley SM, Robinson S, Sloan AE, Miller RH, Brady-Kalnay SM. Proteolytic cleavage of protein tyrosine phosphatase mu regulates glioblastoma cell migration. Cancer Res. 2009 Sep 1;69(17):6960-8. doi: 10.1158/0008-5472.CAN-09-0863. Epub 2009 Aug 18.
- 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.
Tiffany Hodges, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBK2-ICG in people with Malignant Brain Tumors and Glioma, run by Tiffany Hodges at 2 sites in United States.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 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 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tiffany Hodges, MD ((216) 844-2724, Tiffany.Hodges@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs) (time frame: Up to 14 days after surgery (Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438860, which also lists 14 linked publications.
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 6 Oct 2026.