Brain Tumor, Recurrent Clinical Trial
— TumorGlow(TM)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)
NCT number | NCT03262636 |
Other study ID # | 0822231 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | March 10, 2020 |
Verified date | August 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 363 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria 1. Adult patients 18 years of age and older. 2. Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment 3. Good operative candidate as determined by the treating physician and multidisciplinary team 4. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria 1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery 2. Subjects with a history of iodide allergies 3. Vulnerable patient populations a. Patients unable to participate in the consent process (children and neonates). 4. Patients with non-MRI compatible implanted metallic foreign bodies are excluded from this study" 5. Patients who due to severe claustrophobia cannot tolerate MRI scanning" 6. Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium . 7. Patients with moderate to end-stage renal (kidney) disease, defined as a glomerular filtration rate (GFR) less than 30 mL/day/1.73m2 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determining the sensitivity of ICG uptake and expression in identifying ANS tumor deposits when excited by an imaging probe. | 36 months | ||
Secondary | optimize timing and dose of second window Indocyanine Green during surgery of nervous system tumors, based on sensitivity/specificity. | 36 months |
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