Brain Tumor, Recurrent Clinical Trial
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)
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.
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
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