Brain Tumor, PrimaryPhase 1TumorGlow(TM)NCT03262636
Two-Part Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Nervous System Tumors Compared to Standard of Care, (TumorGlow)
A Phase 1 study testing Indocyanine Green in people with Brain Tumor, Primary and Brain Tumor, Recurrent, run by University of Pennsylvania.
Trial summary
Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per 100,000 for a total count of 343,175 incident tumors based on worldwide population estimates [1]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Brain Tumor, Recurrent
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 10 Mar 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years of age and older.
- Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment
- Good operative candidate as determined by the treating physician and multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Who cannot join
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Subjects with a history of iodide allergies
- Vulnerable patient populations
- Patients unable to participate in the consent process (children and neonates).
- Patients with non-MRI compatible implanted metallic foreign bodies are excluded from this study"
- Patients who due to severe claustrophobia cannot tolerate MRI scanning"
- Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium .
- Patients with moderate to end-stage renal (kidney) disease, defined as a glomerular filtration rate (GFR) less than 30 mL/day/1.73m2
About this study
Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per 100,000 for a total count of 343,175 incident tumors based on worldwide population estimates [1]. These entities result in variable but disappointing rates of survival, particularly for primary brain tumors (5-year survival rates: anaplastic astrocytoma 27%; glioblastoma multiforme 5%) [2, 3]. Metastatic brain tumors outnumber primary brain tumors (estimates as high as 10:1) as they affect approximately 25% of patients diagnosed with cancer [4-6]. In terms of brain tumor surgery, the extent of surgical resection-a factor that is greatly impacted by a Neurosurgeon's ability to visualize these tumors-is directly associated with patient outcomes and survival [7-9]. Although spinal cord tumors are lower in terms of their incidence [10], data correlating extent-of-resection to outcomes and survival have been demonstrated in patients with intramedullary tumors [11].
Using systemically delivered compounds with a high sensitivity of detection by near-infrared (NIR) fluorescence, it would be possible for us to improve surgical resection thus minimizing chances of recurrence and improving survival. Simply, if the tumor cells will "glow" during surgery, the surgeons are more likely to identify tumor margins and residual disease, and are, therefore more likely to perform a superior cancer operation. By ensuring a negative margin through NIR imagery, it would make it possible to decrease the rates of recurrence and thus improve overall survival.
Read more
This concept of intraoperative molecular imaging requires two innovations:
(i) a fluorescent contrast agent that can be injected systemically into the subject and that selectively accumulates in the tumor tissues, and (ii) an imaging system that can detect and quantify the contrast agent in the tumor tissues.[12, 13]
Subjects undergo intraoperative imaging, receiving an injection of indocyanine green and then undergoing intraoperative imaging of the surgery site with a NIR imaging system. The imaging devices allow the operating field to be observed in real-time.
Read the detailed description
Indocyanine green is a water-soluble tricarbocyanine dye routinely used in clinical settings for measuring cardiac output, hepatic function, liver blood flow and ophthalmic angiography and has been in use for over 60 years [14]. This protocol utilizes Patheon's indocyanine green, NDC 17238-424. The chemical formula is C45H47N2O6S2Na and the compound has a molecular weight of 774.96Da (CAS number 3599-32-4). It has a peak absorption in the NIR spectrum at 800nm and maximal emission at 835nm. Indocyanine green is rapidly and completely bound to plasma proteins (especially albumin) after intravenous (IV) injection in the blood [15].
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP, which is used to dissolve the indocyanine green, and is to be administered intravenously
- Conditions
- Brain Tumor, Primary, Brain Tumor, Recurrent
- Being tested
- Indocyanine Green
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Indocyanine Green
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic value of Second Window ICG | Other | The primary study objective is to determine the diagnostic value of Second Window ICG (delayed, high dose IV administration of ICG) in the surgical resection of nervous system tumors.
The first objective is to determine safety/efficacy of high dose, delayed indocyanine green (second window ICG) during surgery of nervous system tumors. Receives: Drug: Indocyanine Green |
| Optimal timing and dose of SWG | Other | The second study objective is to calculate diagnostic test characteristics (sensitivity/specificity) of delayed, high dose indocyanine green (second window ICG) as a diagnostic aid during surgery of nervous system tumors.
The third study objective is to optimize timing and dose of second window Indocyanine Green during surgery of nervous system tumors, based on sensitivity/specificity. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the sensitivity of ICG uptake and expression in identifying ANS tumor deposits when excited by an imaging probe.
Measured: 36 months
Secondary outcomes (1)
optimize timing and dose of second window Indocyanine Green during surgery of nervous system tumors, based on sensitivity/specificity.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startJun 2015
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Y.K. Lee, MD, Principal investigator, UPENN Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262636
- Sponsor's protocol ID
- 0822231
- Acronym
- TumorGlow(TM)
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2016
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ostrom QT, Gittleman H, Liao P, Rouse C, Chen Y, Dowling J, Wolinsky Y, Kruchko C, Barnholtz-Sloan J. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol. 2014 Oct;16 Suppl 4(Suppl 4):iv1-63. doi: 10.1093/neuonc/nou223. No abstract available.
PubMed 25304271Li C, Buch L, Cho S, Lee JYK. Near-infrared intraoperative molecular imaging with conventional neurosurgical microscope can be improved with narrow band "boost" excitation. Acta Neurochir (Wien). 2019 Nov;161(11):2311-2318. doi: 10.1007/s00701-019-04054-5. Epub 2019 Sep 3.
PubMed 31482242
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Nervous System Tumors Compared to Standard of Care, (TumorGlow)
- ClinicalTrials.gov ID
- NCT03262636
- Acronym / sponsor ID
- TumorGlow(TM) / 0822231
- Conditions
- Brain Tumor, Primary, Brain Tumor, Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 25 Aug 2017 (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.
Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per 100,000 for a total count of 343,175 incident tumors based on worldwide population estimates [1]. These entities result in variable but disappointing rates of survival, particularly for primary brain tumors (5-year survival rates: anaplastic astrocytoma 27%; glioblastoma multiforme 5%) [2, 3]. Metastatic brain tumors outnumber primary brain tumors (estimates as high as 10:1) as they affect approximately 25% of patients diagnosed with cancer [4-6]. In terms of brain tumor surgery, the extent of surgical resection-a factor that is greatly impacted by a Neurosurgeon's ability to visualize these tumors-is directly associated with patient outcomes and survival [7-9]. Although spinal cord tumors are lower in terms of their incidence [10], data correlating extent-of-resection to outcomes and survival have been demonstrated in patients with intramedullary tumors [11].
Using systemically delivered compounds with a high sensitivity of detection by near-infrared (NIR) fluorescence, it would be possible for us to improve surgical resection thus minimizing chances of recurrence and improving survival. Simply, if the tumor cells will "glow" during surgery, the surgeons are more likely to identify tumor margins and residual disease, and are, therefore more likely to perform a superior cancer operation. By ensuring a negative margin through NIR imagery, it would make it possible to decrease the rates of recurrence and thus improve overall survival.
This concept of intraoperative molecular imaging requires two innovations:
(i) a fluorescent contrast agent that can be injected systemically into the subject and that selectively accumulates in the tumor tissues, and (ii) an imaging system that can detect and quantify the contrast agent in the tumor tissues.[12, 13]
Subjects undergo intraoperative imaging, receiving an injection of indocyanine green and then undergoing intraoperative imaging of the surgery site with a NIR imaging system. The imaging devices allow the operating field to be observed in real-time.
Detailed description
Indocyanine green is a water-soluble tricarbocyanine dye routinely used in clinical settings for measuring cardiac output, hepatic function, liver blood flow and ophthalmic angiography and has been in use for over 60 years [14]. This protocol utilizes Patheon's indocyanine green, NDC 17238-424. The chemical formula is C45H47N2O6S2Na and the compound has a molecular weight of 774.96Da (CAS number 3599-32-4). It has a peak absorption in the NIR spectrum at 800nm and maximal emission at 835nm. Indocyanine green is rapidly and completely bound to plasma proteins (especially albumin) after intravenous (IV) injection in the blood [15].
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP, which is used to dissolve the indocyanine green, and is to be administered intravenously
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic value of Second Window ICG | Other | Drug: Indocyanine GreenThe primary study objective is to determine the diagnostic value of Second Window ICG (delayed, high dose IV administration of ICG) in the surgical resection of nervous system tumors. The first objective is to determine safety/efficacy of high dose, delayed indocyanine green (second window ICG) during surgery of nervous system tumors. |
| Optimal timing and dose of SWG | Other | Drug: Indocyanine GreenThe second study objective is to calculate diagnostic test characteristics (sensitivity/specificity) of delayed, high dose indocyanine green (second window ICG) as a diagnostic aid during surgery of nervous system tumors. The third study objective is to optimize timing and dose of second window Indocyanine Green during surgery of nervous system tumors, based on sensitivity/specificity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 18 years of age and older.
- Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment
- Good operative candidate as determined by the treating physician and multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (8 listed)
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Subjects with a history of iodide allergies
- Vulnerable patient populations
- Patients with non-MRI compatible implanted metallic foreign bodies are excluded from this study"
- Patients who due to severe claustrophobia cannot tolerate MRI scanning"
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGIndocyanine Green | Drug | Diagnostic value of Second Window ICG, Optimal timing and dose of SWG |
Primary outcome
Determining the sensitivity of ICG uptake and expression in identifying ANS tumor deposits when excited by an imaging probe.
Time frame: 36 months
1 secondary outcome
optimize timing and dose of second window Indocyanine Green during surgery of nervous system tumors, based on sensitivity/specificity.
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 25304271Ostrom QT, Gittleman H, Liao P, Rouse C, Chen Y, Dowling J, Wolinsky Y, Kruchko C, Barnholtz-Sloan J. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2007-2011. Neuro Oncol. 2014 Oct;16 Suppl 4(Suppl 4):iv1-63. doi: 10.1093/neuonc/nou223. No abstract available.
- Derived from this study: PubMed 31482242Li C, Buch L, Cho S, Lee JYK. Near-infrared intraoperative molecular imaging with conventional neurosurgical microscope can be improved with narrow band "boost" excitation. Acta Neurochir (Wien). 2019 Nov;161(11):2311-2318. doi: 10.1007/s00701-019-04054-5. Epub 2019 Sep 3.
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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.
John Y.K. Lee, MD principal investigator
UPENN Neurosurgery
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine Green in people with Brain Tumor, Primary and Brain Tumor, Recurrent, run by University of Pennsylvania.
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 4 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determining the sensitivity of ICG uptake and expression in identifying ANS tumor deposits when excited by an imaging probe. (time frame: 36 months). 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 NCT03262636, which also lists 2 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 23 Jan 2026.